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Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the Cupid female condoms: A randomised controlled non-inferiority crossover trial

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Background New designs of female condom have been developed to reduce costs and improve acceptability. To secure regulatory approvals, clinical studies are needed to verify performance. We aimed to assess the functional performance and safety of three new condom types—the Woman's Condom, the VA worn-of-women (wow) Condom Feminine, and the Cupid female condom—against the existing second-generation female condom (FC2). Methods We did a randomised controlled, non-inferiority, four-period crossover trial at three sites in Shanghai, China, and one site in Durban, South Africa, between May 1, 2011, and Jan 31, 2012. Participants aged 18—45 years who were sexually active, monogamous, not pregnant, and not sex workers, were eligible for inclusion if they were literate, had no known allergies to the study products; used a reliable, non-barrier method of contraception, and had no visible or reported sexually transmitted infections. We used a computer-generated randomisation sequence with a Williams square design of size four to assign patients (1:1:1:1) to the FC2 control device, or the Woman's, VA wow, or Cupid condoms, with 12 potential allocations. Randomisation was stratified by site. Participants were not masked to condom type, but allocation was concealed from study investigators. The primary non-inferiority endpoints were total clinical failure and total female condom failure, with a non-inferiority margin of 3%. Women were asked to use five of each condom type and were interviewed after use of each type. We also assessed safety data for each type. We did both per-protocol and intention-to-treat analyses. We calculated frequencies and percentages for each failure event and estimated differences in performance with a generalised estimating equation model. This study is registered, number DOH-27-0113-4271. Findings 616 women were assessed for eligibility, of whom 600 were randomly assigned to condom-type order (30, 120, and 150 women in the three sites in China, and 300 women in the site in South Africa). 572 women completed follow-up, with at least one condom of each type. Total female condom failure was 3·43% for FC2, 3·85% for the Woman's Condom (difference 0·42%, 90% CI −1·42 to 2·26), 3·02% for VA wow (—0·42%, −1·86 to 1·32), and 4·52% for Cupid (1·09%, −0·60 to 2·78); total clinical failure was 2·88%, 3·05% (0·17%, −1·48 to 1·81), 2·49% (—0·25%, −1·75 to 1·26), and 3·87% (0·99%, −0·55 to 2·52), respectively. Only two (<1%) participants, in South Africa, reported serious adverse events, unrelated to use of the study products. Interpretation Non-inferiority was shown for all condom failure events for the three new devices versus the FC2, within the predefined margin. Funding Universal Access to Female Condoms (UAFC).
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Articles
www.thelancet.com/lancetgh Vol 1 September 2013 e
146
Performance and safety of the second-generation female
condom (FC2) versus the Woman’s, the VA worn-of-women,
and the Cupid female condoms: a randomised controlled
non-inferiority crossover trial
Mags E Beksinska, Gilda Piaggio, Jennifer A Smit, Junqing Wu, Yufeng Zhang, Jacqueline Pienaar, Ross Greener, Ying Zhou, Carol Joanis
Summary
Background New designs of female condom have been developed to reduce costs and improve acceptability. To secure
regulatory approvals, clinical studies are needed to verify performance. We aimed to assess the functional performance
and safety of three new condom types—the Woman’s Condom, the VA worn-of-women (wow) Condom Feminine,
and the Cupid female condom—against the existing second-generation female condom (FC2).
Methods We did a randomised controlled, non-inferiority, four-period crossover trial at three sites in Shanghai, China,
and one site in Durban, South Africa, between May 1, 2011, and Jan 31, 2012. Participants aged 18–45 years who were
sexually active, monogamous, not pregnant, and not sex workers, were eligible for inclusion if they were literate, had no
known allergies to the study products; used a reliable, non-barrier method of contraception, and had no visible or reported
sexually transmitted infections. We used a computer-generated randomisation sequence with a Williams square design
of size four to assign patients (1:1:1:1) to the FC2 control device, or the Woman’s, VA wow, or Cupid condoms, with
12 potential allocations. Randomisation was stratifi ed by site. Participants were not masked to condom type, but allocation
was concealed from study investigators. The primary non-inferiority endpoints were total clinical failure and total female
condom failure, with a non-inferiority margin of 3%. Women were asked to use fi ve of each condom type and were
interviewed after use of each type. We also assessed safety data for each type. We did both per-protocol and intention-to-
treat analyses. We calculated frequencies and percentages for each failure event and estimated diff erences in performance
with a generalised estimating equation model. This study is registered, number DOH-27-0113-4271.
Findings 616 women were assessed for eligibility, of whom 600 were randomly assigned to condom-type order (30, 120,
and 150 women in the three sites in China, and 300 women in the site in South Africa). 572 women completed follow-
up, with at least one condom of each type. Total female condom failure was 3·43% for FC2, 3·85% for the Woman’s
Condom (diff erence 0·42%, 90% CI –1·42 to 2·26), 3·02% for VA wow (–0·42%, –1·86 to 1·32), and 4·52% for
Cupid (1·09%, –0·60 to 2·78); total clinical failure was 2·88%, 3·05% (0·17%, –1·48 to 1·81), 2·49% (–0·25%,
–1·75 to 1·26), and 3·87% (0·99%, –0·55 to 2·52), respectively. Only two (<1%) participants, in South Africa, reported
serious adverse events, unrelated to use of the study products.
Interpretation Non-inferiority was shown for all condom failure events for the three new devices versus the FC2,
within the predefi ned margin.
Funding Universal Access to Female Condoms (UAFC).
Introduction
Evidence is scarce about the eff ect of choice of
contraceptive method on increased uptake of methods;
however, a systematic review1 in 2006 supported the
theory that increased contraceptive choice for women is
associated with increased uptake and better health
outcomes (eg, lower pregnancy rates and fewer sexually
transmitted infections [STIs]). Furthermore, women
continue use of their chosen contraceptives to a greater
degree than do those who are denied a choice.2 The female
condom is a barrier method that could increase choice for
women worldwide. Although distribution of female
condoms continues to increase worldwide, doubling
from 25 million to 50 million units between 2007 and
2010, it is substantially lower than that for male condoms,
and accounts for only 0·19% of global condom
procurement.3 In 2011, the female condom was identifi ed
by the Reproductive Health Supplies Coalition as one of
several underused reproductive health technologies that
could expand choice in reproductive health and family
planning programmes, add value to the method mix, and
respond to the needs of various clients.4
Several new female condoms in the fi nal stages of
development, or that have recently become available, aim
to reduce unit cost or improve acceptability.5 The fi rst-
generation female condom (FC1), made by the Female
Health Company, was approved by the US Food and Drug
Administration (US FDA) in 1993 (now discontinued).
Classifi ed as class 3 medical devices by the US FDA, the
regulatory process for female condoms is more complex
Lancet Glob Health 2013;
1: e146–52
See Comment page e119
Copyright © Beksinska et al.
Maternal, Adolescent and Child
Health (MatCH), Department
of Obstetrics and Gynaecology,
Faculty of Health Sciences,
University of the
Witwatersrand, Johannesburg,
South Africa
(M E Beksinska PhD,
J A Smit PhD, J Pienaar MSc,
R Greener MSocSc); Faculty of
Epidemiology and Population
Health (M A Beksinska) and
Department of Medical
Statistics (G Piaggio PhD),
London School of Hygiene and
Tropical Medicine, London, UK;
School of Pharmacy and
Pharmacology, Faculty of
Health Sciences, University of
KwaZulu-Natal, Durban, South
Africa (J A Smit); Department of
Epidemiology and Social
Science on Reproductive
Health, Shanghai Institute of
Planned Parenthood Research,
Fudan University, Shanghai,
China (J Wu PhD, Y Zhang MSc,
Y Zhou MSc); and Joanis
Consulting, Kennesaw, GA. USA
(C Joanis BSc)
Correspondence to:
Dr Mags Beksinska, Maternal,
Adolescent and Child Health
(MatCH), Department of
Obstetrics and Gynaecology,
Faculty of Health Sciences,
University of the Witwatersrand,
Overport, Durban 4091,
South Africa
mbeksinska@match.org.za
Open access under CC BY-NC-ND license.
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than that for male condoms. This diff erence was
compounded by the absence, until 2011, of an
international standard to verify the quality of new devices.
To secure regulatory approvals, including WHO–UNFPA
prequalifi cation, manufacturers need to do clinical
studies to verify the performance of new designs of
female condoms. In 2009, the US FDA approved the
second-generation female condom (FC2) on the basis of
results of a non-inferiority study6 in which the
investigators compared the functional performance of
FC2 with that of FC1 with respect to condom failure
events. Studies of the functional performance of condoms
typically collect detailed data for small numbers of
condom uses (fi ve to ten uses) in a short period of time
(4–6 weeks). Conversely, studies of condom eff ectiveness
for prevention of pregnancy should be done over at least a
6 month period and are far more costly to do than are
functional performance studies. Studies of contraceptive
eff ectiveness were not needed for US FDA approval for
FC2 and no studies of contraceptive eff ectiveness have
been published for FC2. If new female condoms are non-
inferior to FC2 in function, choices will increase and
individual needs can be considered for women wanting to
prevent pregnancy and STIs and HIV. We assessed the
functional performance and safety of three new female
condom designs: the Woman’s Condom, the VA worn-of-
women (wow) Condom Feminine, and the Cupid female
condom versus the FC2 device.
Methods
Study design and participants
We undertook this four-period, randomised, non-
inferiority, crossover, clinical trial between May 1, 2011,
and Jan 31, 2012, at three centres in Shanghai, China (the
Shanghai Institute of Planned Parenthood Research
Hospital and two affi liated family planning districts—
XuJiahui and Xuhui), and one centre in Durban, South
Africa (an urban reproductive health clinic). Participants
aged 18–45 years who were sexually active, monogamous,
and not practising sex workers, were eligible for inclusion
if they had no known allergies to the study products
(latex, synthetic latex, polyurethane); used a reliable, non-
barrier method of contraception; and had no STIs (as
established by pelvic examination and use of a syndromic
diagnostic approach). Participants could be novice or
experienced users of condoms, but had to be literate
because take-home condom logs were used to obtain
data. We excluded pregnant women (established by urine
Figure 1: Trial profi le
The numbers of women withdrawing after period one were two for the sequence CWVF, three for FVWC, none for VCFW, and three for WFCV; after period two were three, two, one, and two,
respectively; and for period three were three, two, one, and two, respectively. C=Cupid. W=Woman’s Condom. V=VA worn-of-women. F=second-generation female condom (FC2).
75 CWVF 75 FVWC 75 VCFW 75 WFCV 50 CVFW 50 VWFC 50 WFVC 50 FCWV 25 VFWC 25 CWFV 25 FCVW 25 WVCF
66 included
in main
analysis
66 included
in main
analysis
70 included
in main
analysis
70 included
in main
analysis
50 included
in main
analysis
50 included
in main
analysis
50 included
in main
analysis
50 included
in main
analysis
25 included
in main
analysis
25 included
in main
analysis
25 included
in main
analysis
25 included
in main
analysis
1 used no
condom
1 lost to
follow-up
8 did not
use all
condom
types
3 lost to
follow-
up
5 for non-
safety
reasons
66 used all
condom
types
2 used no
condom
2 for non-
safety
reasons
7 did not
use all
condom
types
1 lost to
follow-
up
6 for non-
safety
reasons
66 used all
condom
types
5 did not
use all
condom
types
3 lost to
follow-
up
2 for non-
safety
reasons
70 used all
condom
types
5 did not
use all
condom
types
1 lost to
follow-
up
4 for non-
safety
reasons
70 used all
condom
types
50 used all
condom
types
50 used all
condom
types
50 used all
condom
types
50 used all
condom
types
25 used all
condom
types
25 used all
condom
types
25 used all
condom
types
25 used all
condom
types
600 randomised
16 excluded
16 did not meet inclusion criteria
616 women assessed for eligibility
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pregnancy test). Participants from the South African site
were similar in profi le and recruited from the same site
as that in the study used to establish the comparative
performance of the reference condom (FC2) to the
predicate device, FC1.6 Participants gave written informed
consent before screening and enrolment.
The study was approved by the institutional review
boards of the University of Witwatersrand Human
Research Ethics Committee in South Africa and the
Ethical Committee of Shanghai Institute of Planned
Parenthood Research in China. The study was also
approved by the National Population and Family Planning
Commission (NPFPC) in China and by the provincial,
district, and local departments of health in South Africa.
Male partners were informed of the study through use of
a fact sheet, which explained the purpose of the study and
provided information about the study products and their
role in the research. Our study methods are based on the
recommendations of WHO–UNFPA.7
Randomisation and masking
We used a computer-generated randomisation sequence
(SAS version 9.38) to assign patients to one of 12 se-
quences of condom use (fi gure 1). Randomisation was
stratifi ed by site. We used a Williams design, which
consisted of the random construction of a Williams
square (fi rst step) and the random allocation of women
to the treatment sequences, independently at each site
(second step).9 These sequences were balanced for
period and treatment, and each treatment had a
diff erent preceding treatment. To ensure such balance,
the Williams design uses block sizes of four in a Latin
square.
To devise a simple and eff ective method of concealment,
we designed a scratch card per participant, containing
the allocated treatment sequence, whereby each code for
a given condom type was concealed beneath a separate
foil square. For each card, research staff would remove
(scratch) the foil corresponding to the visit number
printed above the square, thereby revealing the next visit
allocation in the sequence. This novel adaption of an
existing technology had not been previously reported for
concealment of the allocation sequence in a randomised
crossover trial. The development and use of the cards for
this trial has been reported elsewhere.10 Participants were
not masked to condom type because the designs are all
quite distinct and required product-specifi c training.
Procedures
Our primary objective was to compare the functional
performance of the four types of female condom within
the selected study populations (fi gure 2). The FC2 was
the control device, because the predicate device (FC1)
ceased production in 2009. Each condom product was
shipped by the manufacturer to Family Health
International (now FHI 360) for quality assurance testing
to ensure that products were of the quality specifi ed by
The second-generation female condom (FC2)
In 2009, the FC2 replaced the polyurethane first-generation female
condom (FC1; trade names include Reality and Femidom), which had
been available since 1993. FC2 is similar in specification and
appearance to FC1, but is made of synthetic nitrile rubber latex. FC2
has a flexible inner ring to insert the device and keep it in place during
use. A ring at the open end lies flat across the genital area. FC2 was
regarded as acceptable for bulk procurement by all UN agencies in 2007.
In 2009, FC2 was approved by the US Food and Drug Administration.
The Woman’s Condom
The Woman’s Condom, designed and developed by the Program for
Appropriate Technology in Health (PATH), is made of polyurethane.
The condom sheath is tucked into an insertion capsule that dissolves
after insertion. The four foam dots on the body of the condom ensure
internal stability. The condom is not pre-lubricated and is supplied with
a water-based lubricant. Licensed to the Dahua Medical Apparatus
Company (Shanghai, China), the Woman’s Condom received the
CE Mark of the European Union in 2010, and the approval of the
Shanghai Food and Drug Administration in 2011.
The VA wow Condom Feminine
The VA wow condom (Medtech Products, India) is made of natural
rubber latex and encases a medical-grade sponge at the closed end.
The sponge is used for insertion and the outer anchoring structure has
a triangular-shaped frame. The condom is lubricated with silicone oil.
The device carries the CE Mark of the EU, and has approvals from the
India Drug Control Authority and the Ministry of Health in Brazil.
The Cupid female condom
The Cupid condom (Cupid, India), manufactured in India, is available in
some European and African countries. Made of natural rubber latex, the
condom has an octagonal outer frame and is inserted with a medical-
grade sponge, which also holds the condom in place during use. The
device is pre-lubricated with silicone oil and comes in natural latex and
pink colours. The Cupid condom is the only scented condom of all those
assessed. The condom holds the CE Mark of the EU, is prequalified by
WHO–UN Population Fund and registered by the India Drug
Control Authority.
A
B
C
D
Figure 2: Description of study products
Panel 1: Defi nitions of failure modes
Total clinical failure: the number of female condoms that clinically break or slip, or that are
associated with misdirection, invagination, or any additional failure modes identifi ed in
the risk assessment, which result in reduction of the protective function of the condom
Total condom failure: a female condom for which a non-clinical breakage, clinical
breakage, or slippage occurs, or that is associated with misdirection, invagination,
or any additional failure modes identifi ed in the risk assessment
Clinical breakage: breakage of the condom during sexual intercourse or during withdrawal
of the female condom from the vagina (potential adverse clinical consequences)
Non-clinical breakage: breakage noticed before intercourse or occurring after
withdrawal of the condom from the vagina (no potential adverse clinical consequences)
Total breakage: the number of all condom breakages at any time before, during,
or after sexual intercourse; includes both clinical and non-clinical breakages
Slippage: when a female condom slips completely out of the vagina during sexual
intercourse
Misdirection: vaginal penetration whereby the penis is inserted between the condom
and the vaginal wall
Invagination: when the external retention feature of the female condom is partly or
fully pushed into the vagina during sexual intercourse
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the manufacturer and met International Organization
for Standardization (ISO 25841-2011) requirements.7
The primary endpoints were self-reported total
clinical failure and total female condom failure.
Additionally, we assessed the component failure events
of clinical breakage, non-clinical breakage, total
breakage, slippage, misdirection, and invagination.11
Panel 1 shows the defi nitions of each failure mode
analysed. We also collected data for safety and
acceptability. Failure events are recognised by WHO
and other regulatory agencies.
Our secondary objectives were to assess the safety and
acceptability of each condom type and to compare
acceptability endpoints between the four types, with
superiority hypotheses. We measured and assessed
safety of each device according to number, severity,
relatedness, and duration of adverse events. We collected
standard acceptability measures and these data will be
reported elsewhere.
In this study, each woman was asked to use fi ve of each
of the four condom types and to complete a condom log
at home after each condom use. After women completed
use of each condom type, they returned to the clinic to be
interviewed about their experiences. Condom logs were
used to obtain data for condom function and safety.
We used interviewer-assisted questionnaires to gather
acceptability and preference data.
Statistical analysis
We calculated the power to show non-inferiority
obtained for diff erent sample sizes, starting with a
minimum of 200 couples completing the study as
recommended by ISO 25841-2011 for functionality
studies of acute failure events with female condoms
based on self-reports.12 We assumed a total failure rate
of 4% for FC2 as reported from previous research,6 and
a correlation between uses of 0·15, as reported for male
condoms.13 With 3% as a clinically determined margin
of non-inferiority and a signifi cance level of 5% for the
hypothesis of non-inferiority, 500 women (250 per
country) completing the study would provide 98%
power in each country. We expected a non-completion
rate of 15% (ie, 85% would provide relevant follow-up
data for at least one condom of each type); therefore, we
increased the sample size to 600 women (300 per
country). In the power calculation, we adjusted for
various comparisons with the Bonferroni criterion.14
The hypothesis for the primary endpoints of total
clinical failure and total female condom failure and their
component failure events, was that each of the three new
condoms was non-inferior to FC2 for the rate of events
within a margin of 3·0%.
The main analysis for primary and secondary endpoints
was according to the assigned condom use sequence in the
subset of participants who provided relevant follow-up data
for at least one condom of each type (per-protocol analysis).
We did an additional analysis with women with complete
or incomplete condom series (one to four condom types,
one to fi ve uses each; data not shown). This additional
analysis was by intention to treat, but with exclusion of
three participants for whom no data about condom
function were available. All analyses were stratifi ed by
country.
To show non-inferiority, the upper limit of the two-sided
90% CI for the diff erence in the occurrence of events (new
condom minus FC2) needed to be below 3·0%. If non-
inferiority was shown, we tested superiority at a 5% level
of signifi cance using a two-sided 95% CI.
We analysed primary endpoints with a generalised
estimating equation approach assuming a binomial
China
(n=300)
South Africa
(n=272)
Total
(N=572)
Age (years)
Mean (SD) 36·3 (5·68) 27·9 (6·29) 32·3 (7·30)
Min–max 21–45 18–44 18–45
Ethnic group
Asian (Chinese) 299 (>99%) 0 299 (52%)
Black 0 271 ( >99%) 271 (47%)
Coloured 0 1 (<1%) 1 (<1%)
White 1 (<1%) 0 1 (<1%)
Completed years of school
0–5 4 (1%) 2 (<1%) 6 (1%)
6–10 79 (26%) 24 (9%) 103 (18%)
11–15 160 (53%) 244 (90%) 404 (71%)
16–20 57 (19%) 2 (<1) 59 (10%)
Primary occupation
Health or medical 39 (13%) 5 (2%) 44 (8%)
None or unemployed 34 (11%) 134 (49%) 168 (29%)
Offi ce, public service, or government 104 (35%) 4 (1%) 108 (19%)
Sales 33 (11%) 12 (4%) 45 (8%)
Self employed or other 51 (17%) 21 (8%) 72 (13%)
Student 50 (18%) 50 (9%)
Teacher or lecturer 6 (2%) 3 (1%) 9 (2%)
Technical 13 (4%) 1 (<1) 14 (2%)
Unskilled labour 20 (7%) 42 (15%) 62 (11%)
Number of living children
0 20 (7%) 50 (18%) 70 (12%)
1 266 (89%) 117 (43%) 383 (67%)
2 14 (5%) 70 (26%) 84 (15%)
≥3 35 (13%) 35 (6%)
Civil status
Married or living together 298 (99%) 62 (23%) 360 (63%)
Not married and not living together 2 (<1%) 210 (77%) 212 (37%)
Duration of relationship with current spouse or partner
<1 year 4 (1%) 17 (6%) 21 (4%)
1–5 years 61 (20%) 156 (57%) 217 (38%)
6–10 years 57 (19%) 58 (21%) 115 (20%)
>10 years 178 (59%) 41 (15%) 219 (38%)
Data are number of individuals (%) unless otherwise indicated.
Table 1: Baseline sociodemographic characteristics of the main analysis population by country and overall
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distribution, and with an identity link function, including
type of condom in the model at the couple-use level and
defi ning couples as clusters, to take into account the
crossover nature of the design. We used an
interchangeable error structure within couples and
adjusted results by multiplicity with Scheff é’s method.13
This trial is registered, number DOH-27-0113-4271.
Role of the funding source
The sponsor of the study had no role in study design, data
collection, data analysis, data interpretation, or writ ing of
the report. MEB, GP, JP, RG, and CJ had full access to the
primary data. All other authors (JAS, JW, YZha, and YZho)
had access to the data collected in their own country. All
authors had fi nal responsibility for the publication.
Results
Figure 1 shows the trial profi le. 600 women were enrolled
in the study (300 per country). 572 (95%) women
completed the study with each woman using at least one
condom of each of the four types. These women comprise
the main analysis population. Only three women, in
South Africa, did not use any condom.
Chinese participants were older than participants from
South Africa (table 1). Women in both countries were
well educated, with 72% in China and 90% in South
Africa having more than 10 years of schooling (table 1).
Most Chinese participants were married or living with
their partners, whereas most South African participants
were not married or residing with their partners (table 1).
188 (63%) of 300 Chinese participants and 272 (100%) of
South African participants had used male condoms
previously, whereas 39 (14%) of South African women
had previous experience with female condoms compared
with no participants in China.
11 350 female condoms were used in this study by
women in the main analysis population (2838 Cupid,
2850 FC2, 2827 VA wow. and 2835 Women’s Condoms).
Table 2 shows the mean failure rate and failure diff erence
of Cupid, VA wow, and Woman’s Condom compared
with FC2 for both countries combined. Non-inferiority
was shown, within the non-inferiority margin, for all
failure modes for the three new devices versus FC2 (data
not shown) and for the two countries combined (table 2
and fi gure 3). The additional analysis done with women
with complete or incomplete condom series provided
similar results (data not shown).
We noted no evidence of superiority for any of the new
condoms compared with FC2 in any of the failure modes
(table 2).
Overall, the occurrence of adverse events and medical
problems for the enrolled population was low (data not
shown). Only two (<1%) participants in South Africa
reported serious adverse events, unrelated to use of the
study products. 27 (5%) adverse events were reported in
the 597 women using at least one condom at least once.
Adverse events occurred in fewer than 1% (range
0·14–0·38%) of participants for each condom type.
Adverse event reports were vaginal burning (fi ve with VA
wow in China); vaginal itching (one with Cupid, one with
FC2, and one with Women’s Condom in South Africa);
Mean failure
rate (%)
Failure diff erence (%) p value
Diff erence
with FC2
90% CI 95% CI
Clinical breakage*
Cupid 0·10 NE NE NE ··
VA wow 0·08 NE NE NE ··
WC 0·00 NE NE NE ··
FC2 0·25 NE NE NE ··
Non-clinical breakage
Cupid 0·66 0·04 –0·61 to 0·69 –0·69 to 0·77 0·9991
VA wow 0·53 –0·09 –0·52 to 0·33 –0·57 to 0·38 0·9586
WC 0·74 0·12 –0·41 to 0·65 –0·47 to 0·71 0·9557
FC2 0·62 (Ref) ·· ·· ··
Total breakage
Cupid 0·77 –0·05 –0·76 to 0·66 –0·84 to 0·74 0·9984
VA wow 0·67 –0·14 –0·67 to 0·38 –0·73 to 0·44 0·9226
WC 0·84 0·02 –0·57 to 0·60 –0·63 to 0·67 0·9999
FC2 0·82 (Ref) ·· ·· ··
Invagination
Cupid 1·21 0·03 –0·85 to 0·91 –0·95 to 1·01 0·9999
VA wow 0·99 –0·20 –1·17 to 0·77 –1·28 to 0·89 0·9684
WC 0·47 –0·72 –1·46 to 0·03 –1·55 to 0·12 0·1247
FC2 1·18 (Ref) ·· ·· ··
Misdirection
Cupid 1·22 0·62 –0·12 to 1·37 –0·21 to 1·46 0·2264
VA wow 1·19 0·58 –0·21 to 1·37 –0·30 to 1·47 0·3309
WC 1·13 0·53 –0·31 to 1·37 –0·41 to 1·47 0·4759
FC2 0·60 (Ref) ·· ·· ··
Slippage
Cupid 1·48 0·50 –0·41 to 1·42 –0·52 to 1·53 0·5979
VA wow 0·43 –0·55 –1·17 to 0·07 –1·25 to 0·14 0·1760
WC 1·28 0·30 –0·64 to 1·24 –0·75 to 1·35 0·8880
FC2 0·98 (Ref) ·· ·· ··
Total clinical failure
Cupid 3·87 0·99 –0·55 to 2·52 –0·73 to 2·70 0·4614
VA wow 2·49 –0·25 –1·75 to 1·26 –1·92 to 1·43 0·9823
WC 3·05 0·17 –1·48 to 1·81 –1·67 to 2·01 0·9957
FC2 2·88 (Ref) ·· ·· ··
Total female condom failure
Cupid 4·52 1·09 –0·60 to 2·78 –0·80 to 2·98 0·4552
VA wow 3·02 –0·42 –1·86 to 1·32 –2·05 to 1·51 0·9809
WC 3·85 0·42 –1·42 to 2·26 –1·64 to 2·47 0·9553
FC2 3·43 (Ref) ·· ·· ··
NE=not estimable. Cupid=Cupid female condom. VA wow=VA worn-of-women Condom Feminine. WC=Woman’s
Condom. FC2=second-generation female condom. 2-sided 90% CIs for non-inferiority hypothesis at α=5% and 2-sided
95% CIs for superiority hypothesis, with p va lues, adjustment for multiplicity by Scheff é’s method. *Estimated as mean
proportions of 75 women each because generalised estimasting equation model did not converge.
Table 2: Mean failure rate and failure diff erence of Cupid, VA wow, and Woman’s Condom in relation to
FC2, complete condom series population, for both countries
Articles
e151
www.thelancet.com/lancetgh Vol 1 September 2013
vaginal pain or swelling (two with Cupid, two with FC2,
one with VA wow in South Africa); penile itching, burning,
rash, or swelling (one with FC2, two with VA wow, and
one with Women’s Condom in South Africa); general rash
(one with Women’s Condom in China); and unknown,
unclear, or unrelated rash (three with Cupid, two with
FC2, three with VA wow, and one with Women’s Condom
in South Africa). All events resolved without sequelae.
Discussion
Although individual failure rates vary by country and
condom type, the three new devices assessed in this
study were non-inferior to the reference condom (FC2)
within the non-inferiority margin for all the functional
parameters. The rates of total clinical failure, total female
condom failure, and component failure reported were
expected and are consistent with fi ndings from previous,
similarly undertaken studies.6,15–17 Furthermore, the
failure results reported in this study were from two
culturally diverse study populations. That the results are
similar between South Africa and China attests further to
the validity of the fi ndings. These data show that
clinically, the new female condoms assessed function in
a similar way to the FC2. Data from this study have been
used to fi nalise the dossier submitted to WHO–UNFPA
for the Cupid condom and resulted in its prequalifi cation
for public sector procurement in June, 2012.18 The
manufacturer of the Woman’s Condom (Dahua, China)
will use these data to fi nalise their dossier and
submissions to WHO–UNFPA and US FDA. The VA
wow condom is under review by WHO–UNFPA;
however, manufacture of the product is suspended,
possibly related to change of ownership of the factory.
On the basis of fi ndings from this trial, these new
female condoms could be important players in
contraception and STI prevention. The availability of new
types of female condoms will provide donors and users
with more options and could reduce the unit price of
devices.4 Although prediction of how far the price of
female condoms will reduce in the future is not possible,
the Reproductive Health Supplies Coalition has
published information comparing diff erent unit costs to
the donor funded public sector, indicating that the Cupid
female condom, which was prequalifi ed in 2012, will be
sold at a lower price per unit than FC2.4 However, studies
of contraceptive eff ectiveness and those showing
eff ectiveness or reductions in STI incidence with these
new female condoms are still needed.
Contraception is one strategy that can have an eff ect on
and improve maternal health by reducing unplanned
pregnancy. In 2009, estimates showed that if all women
who wanted to avoid pregnancy used modern
contraceptives, the number of unintended pregnancies
in developing countries would fall from 75 million to
22 million annually.19 Reasons for unmet need for
contraception go beyond simple access to methods, and
are attributable to a combination of factors including
personal and cultural issues, religious restrictions,
concern about side-eff ects, health concerns, and scarcity
of knowledge. For this reason, the need to have a range of
available contraceptive methods is crucial (panel 2).
A limitation of our study was that masking of the
participants and research staff to the products was not
possible because the products all diff er in appearance.
We used allocation concealment to ensure that this
limitation was minimised. This study was based on only
self-reported measures of condom use. Reporting of
condom use by participants can be inaccurate compared
with more reliable methods such as exposure to prostate-
specifi c antigen, which provides a more objective
Figure 3: Estimates of the risk diff erence between failure of new female condoms and failure of FC2, for the
primary outcomes of TFCF and TCF, showing the results for non-inferiority
TFCF=total female condom failure. VA wow=VA worn-of-women. TCF=total clinical failure. FC2=second-generation
female condom.
0·42% (–1·42 to 2·26)
–0·42% (–1·86 to 1·32)
1·09% (–0·60 to 2·78)
0·17% (–1·48 to 1·81)
–0·25% (–1·75 to 1·26)
0·99% (–0·55 to 2·52)
TFCF–Woman’s Condom
TFCF–VA wow
TFCF–Cupid
TCF–Woman’s Condom
TCF–VA wow
TCF–Cupid
New condom better FC2 better
Risk difference (90% CI)
–4·00 –3·00 –2·00 –1·00 01·00 2·00 3·00 4·00
Panel 2: Research in context
Systematic review
We searched PubMed between Jan, 2000, and Oct, 2012, for
articles published up to November, 2012, with the search
terms “female condom functional performance”. No
randomised trials, using any of the three new types of female
condom—the Woman’s Condom, the VA worn-of-women
(wow) Condom Feminine, and Cupid—were identifi ed, aside
from one randomised, non-inferiority trial6 used to establish
the functional performance of the second-generation female
condom, FC2, compared with the predicate device (FC1).
Interpretation
This study is the fi rst randomised trial of the functionality of
female condoms in China. The new female condoms were
non-inferior to the reference condom (FC2) within a margin
of 3% failure for all the functional parameters. This is the fi rst
trial that has provided important function data for these
devices and has been used to compile evidence for
WHO–UNFPA prequalifi cation. Because of this trial, the Cupid
condom has already been approved by WHO–UNFPA and is
available for public sector procurement. Manufacturers of the
other devices are using these data in their ongoing
applications to regulatory authorities. Access to various types
of female condoms could improve choice for women in need
of a contraceptive method or of dual protection against
pregnancy and infection.
Articles
www.thelancet.com/lancetgh Vol 1 September 2013 e
152
measure of condom failure.20 However, techniques that
use prostate-specifi c antigen are more expensive and
study procedures more complex.
Contributors
CJ and MEB conceived the study and designed it with GP (statistician);
CJ, MEB, JAS, JW, YZha, RG, and JP managed the undertaking of the
trial. GP was responsible for all statistical analyses, and GP, MEB, CJ,
and JAS interpreted the data. MEB, CJ, GP, JAS drafted the article with
input editing from RG, JP, JW, and YZha. All authors read and approved
the fi nal version for submission.
Confl icts of interest
We declare that we have no confl icts of interest. Since completion of the
study CJ has done paid consultancy work for Cupid, manufacturer of the
Cupid female condom used in this study. In this capacity, she is assisting
with the development of a dossier that will be submitted to the US Food
and Drug Administration for requested approval of the Cupid device. All
data analysis and statistical interpretation and the fi nal statistical report
for this study were fi nalised before CJ accepted the consultancy.
Acknowledgments
This trial was funded by the Universal Access to Female Condoms
(UAFC) Joint Programme. We thank all research nurses, interviewers,
and data entry staff in both participating sites who collected and entered
the data, in particular Claudia Ngoloyi, Gloria Rasi, Li Yuyan, and
Zhaorui Ying; José de Sousa Ramos (JRamos Consultoria, São Paulo,
Brazil) for his valuable contribution to setting up the database and
programming the tables; and all clients who gave their time to
participate in the trial.
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... The study designs include: Two cluster randomised trials [29,30], ten crossover trials including three noninferiority trials [31][32][33][34][35][36][37][38][39], and three randomized controlled trials [40,41]. See Table 1. ...
... Almost half of the study participants were lost to follow-up after 3 months [29]. Six studies were judged as having low attrition rates [30,34,35,38,39,45] and the rest were rated as unclear. Three studies were rated as having low risk of reporting bias, with the rest providing insufficient information to enable judgement, hence judged to have unclear risk of bias. ...
... When we considered the seven studies that compared the new female condoms to the FC2, there was no significant difference in the total clinical failure rates when the cupid/cupid 2 condoms (2 trials, n = 900, RR 1·22 95% CI 0·98 to 1·52) [34,35], Velvet condom (1 trial, n = 300, RR 0·90 95% CI 0·63 to 1·29) [35], Woman's condom/Woman's condom 2 (3 trials, n = 1058, RR 0.84 95% CI 0·68 to 1·04) [34,38,45], Reddy female condom (2 trials, n = 770, RR 0·85 95% CI 0·65 to 1·11) [34,38], and Pheonurse (1 trial, n = 291, RR 1·00 95% CI 0·92 to 1·08) [37] were compared to the FC2. One conference abstract for a trial comparing the Wondaleaf condom to the FC2 reported total clinical failure rates of 5·3% and 7·5% respectively [36]. ...
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Background: The effectiveness of female condoms for preventing HIV and sexually transmitted infections (STIs) remains inconclusive. We examined the effects of female condoms on the acquisition of HIV and STIs. Methods: We searched four databases, two trial registries, and reference lists of relevant publications in October 2018 and updated our search in February 2020. We screened search output, evaluated study eligibility, and extracted data in duplicate; resolving differences through discussion. We calculated the effective sample size of cluster randomised trials using an intra-cluster correlation coefficient of 0·03. Data from similar studies were combined in a meta-analysis. We performed a non-inferiority analysis of new condoms relative to marketed ones using a non-inferiority margin of 3%. We assessed the certainty of evidence using GRADE. Results: We included fifteen studies of 6921 women. We found that polyurethane female condoms (FC1) plus male condoms may be as effective as male condoms only in reducing HIV acquisition (1 trial, n = 149 women, RR 0.07, 95%CI 0.00-1.38; low-certainty evidence). However, the use of FC1 plus male condoms is superior to male condoms alone in reducing the acquisition of gonorrhoea (2 trials, n = 790, RR 0.59, 95%CI 0.41-0.86; high-certainty evidence) and chlamydia (2 trials, n = 790, RR 0.67, 95%CI 0.47-0.94; high-certainty evidence). Adverse events and failure rates of FC1 were very low and decreased during follow up. Although the functionality of newer female condoms (Woman's, Cupid, Pheonurse, Velvet, and Reddy) may be non-inferior to FC2, there were no available studies assessing their efficacy in preventing HIV and STIs. Conclusion: The use of female plus male condoms is more effective than use of male condoms only in preventing STIs and may be as effective as the male condom only in preventing HIV. There is a need for well conducted studies assessing the effects of newer female condoms on HIV and STIs. Prospero registration number: CRD42018090710.
... It has the potential to both empower women and please men [10]. Recent researches have shown that the female condom with trusted efficacy could increase the uptake of condom use, reduce stress caused by unintended pregnancy or STIs, and increase sexual pleasure and health benefits [11,12]. Although female condoms have been marketed internationally since the mid-1990s, they remain relatively unpopular in China, for example, most migrants have never seen a female condom [13]. ...
... Adverse effects caused by female condoms would decrease the acceptability of the Woman's Condom, but incidence of such effects was generally very low [12]. Several studies reported a range of adverse effects from < 2.0% to < 4.0% for various types of female condoms [12,32]. ...
... Adverse effects caused by female condoms would decrease the acceptability of the Woman's Condom, but incidence of such effects was generally very low [12]. Several studies reported a range of adverse effects from < 2.0% to < 4.0% for various types of female condoms [12,32]. In the current study, only 1.8% of adverse effects from the Woman's Condom were reported. ...
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Background: The Woman's Condom, a newly designed condom for women, has obtained market approval in China, but it remains relatively unfamiliar to the migrant population. The aim of this study is to evaluate the short-term acceptability of the Woman's Condom and influencing factors among internal migrants. Methods: A longitudinal study was conducted among 1800 migrants in Beijing, Chongqing, and Shanghai in China between August 2013 and August 2014.Three-level model was implemented with the Statistical Analysis System software (v.9.4 SAS Institute) to analyze within-individual changes, between-individuals effects, and between-group effects. Results: Three-level model analysis revealed statistically higher short-term acceptability of the Woman's Condom among subjects who lived in Shanghai (β = 6.50, t = 2.76, p < 0.01), unmarried and not in a cohabiting relationship (β = 3.05, t = 2.76, p < 0.01) than those who lived in Beijing, married and in a cohabiting relationship. Female (β = - 1.69, t = - 7.55, p < 0.01) and lower educational attainment (β = - 2.30, t = - 1.94, p = 0.05) were negatively related, while occupations of education, health, and civil staff (β = 1.50, t = 2.92, p < 0.01) were positively related to acceptability. It was predicted that migrants' acceptability of the Woman's Condom would significantly increase over time (β = 1.09, t = 5.54, p < 0.01). Conclusions: The findings indicate that the Woman's Condom enjoyed relatively high short-term acceptability among migrants in China. In order to popularize the Women's Condoms in migrants, more publicity, consultation and training in open and prosperous areas should be strengthened.
... Consumer concerns with FC1 about difficulty with insertion or the inner ring being painful or poorly fitting reduce acceptability [9]. Recent female condom designs may improve ease of use and acceptability [10,11]. PATH, an international nonprofit health organization with funding from the United States Agency for International Development (USAID) through CONRAD, developed The Woman's Condom (WC). ...
... An iterative user-centered design process aimed to improve the WC's functionality, acceptability, and ease of insertion compared to prior designs [12]. The WC has shown non-inferior efficacy and safety compared to other female condoms [10,12,13], and studies demonstrate short-term acceptability [14,15]. In this planned analysis, we evaluated WC acceptability in a contraceptive efficacy trial among U.S. women. ...
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... Clinical studies evaluating the efficacy, safety and acceptability of these new designs are ongoing. [15][16][17][18] In comparison with the male condom, the female condom is said to offer additional coverage to both partners and is not weakened by the use of oil-based lubricants. Furthermore, no serious local side effects or allergies have been reported. ...
... 6 24 25 With the advent of newer forms of the female condom, many randomised controlled studies have examined the effectiveness and acceptability of female condoms in preventing HIV and other STIs. [15][16][17][18] Additionally, stereotypes and strong opinions that tend to hamper the acceptance of female condoms exist. These in turn may hinder their correct and consistent use, an aspect that determines the effectiveness of this barrier method in preventing HIV. ...
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... The Cupid female condom 21 uses a medical grade sponge and the "V" Women's condom (developed by PATH) uses a dissolving cap for insertion and foam shapes on the central part of the condom body and therefore there is no retention feature that would interfere with the vaginal ring. 21 The rates of condom use (male and female) at last sex show a positive trend in many regions with some Latin American and European countries reporting rates among 15-24-year-olds of more than 80%, although lower increase of around 30% have been recorded in some African countries. 1 In particular, condom use at last higher-risk sex has increased over the past 3 decades in most countries across the world and is as high as 80%-90% in some countries. ...
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A Williams design is a special and useful type of cross-over design. Balance is achieved by using only one particular Latin square if there are even numbers of treatments, and by using only two appropriate squares if there are odd numbers of treatments. PROC PLAN of SAS/STAT is a practical tool, not only for random construction of the Williams square, but also for randomly assigning treatment sequences to the subjects, which makes integration of the two procedures possible. The present paper provides a general SAS program for the random construction of a Williams design and the relevant procedure for randomization. Examples of a three-treatment, three-period (3 3) and a four-treatment, four-period (4 4) cross-over designs are given to illustrate the function of the SAS program. The results can be regenerated and replicated with the same random number seed. The gen- eral SAS program meets the practical needs of researchers in the application of Williams designs.
Article
Male and female condoms are currently the only effective dual protection methods against unintended pregnancy and transmission of STIs and HIV. In recent years, advocacy and support to female condom (FC) programmes and increased distribution have played a significant role in highlighting to donors, policy-makers and programme managers the importance of FCs as essential tools for dual prevention. Further, the emergence of new FC products, differing in design and materials, has the potential to lower cost and improve acceptability. There are hurdles in developing new FC products, by far the greatest being the clinical studies required for regulatory purposes. However, several new designs are now available in selected countries and some are progressing through the final stages of regulatory approval, after which they will be more widely available. The new FC designs, which may also be more affordable, will increase options and choice for couples who want to use FCs as their prevention method. Here, we review the FC products that are available now and those still in development which are expected to be available within the next two to five years. Résumé Les préservatifs masculins et féminins sont actuellement les seules méthodes efficaces de double protection contre les grossesses non désirées et la transmission des IST et du VIH. Ces dernières années, le plaidoyer et le soutien aux programmes de préservatif féminin et la distribution accrue de ces produits ont joué un rôle important pour insister auprès des donateurs, des décideurs et des responsables de programmes sur l'importance du préservatif féminin comme outil essentiel de la double prévention. De plus, l'apparition de nouveaux produits, différents en conception et matériel, peut en diminuer coût et améliorer l'acceptabilité. La conception de nouveaux préservatifs féminins rencontre des écueils, le principal étant les études cliniques nécessaires à des fins régulatrices. Néanmoins, plusieurs nouveaux produits sont maintenant disponibles dans des pays sélectionnés et d'autres se rapprochent du stade final de l'agrément, après quoi ils deviendront largement disponibles. Ces nouveaux produits, qui seront peut-être aussi plus abordables, multiplieront les options et les choix pour les couples qui veulent utiliser le préservatif féminin comme méthode de prévention. Nous étudions ici les préservatifs féminins disponibles et ceux qui sont en cours d'élaboration et devraient être commercialisés d'ici deux à cinq ans. Resumen Actualmente, los condones masculinos y femeninos son los únicos métodos eficaces de doble protección contra el embarazo no intencional y la transmisión de ITS y VIH. En los últimos años, la promoción y defensa de programas de condón femenino (CF) y mayor distribución han desempeñado un papel decisivo en recalcar a donantes, formuladores de políticas y gerentes de programas la importancia de los CF como herramientas esenciales para la doble prevención. Más aún, la emergencia de nuevos productos de CF, que difieren en diseño y materiales, tiene el potencial de reducir el costo y mejorar su aceptación. Existen obstáculos para crear nuevos productos de CF; el mayor es los estudios clínicos exigidos para fines normativos. Sin embargo, en algunos países ahora hay varios diseños disponibles y algunos están progresando hacia las etapas finales de la aprobación reglamentaria, tras la cual estarán disponibles de manera más extendida. Los nuevos diseños de CF, que posiblemente sean menos costosos, ampliarán las opciones de parejas que desean usar CF como método de prevención. Aquí se revisan los productos de CF actualmente disponibles y aquellos aún en desarrollo, que se espera estén disponibles en los próximos dos a cinco años.
Article
Male and female condoms are currently the only effective dual protection methods against unintended pregnancy and transmission of STIs and HIV. In recent years, advocacy and support to female condom (FC) programmes and increased distribution have played a significant role in highlighting to donors, policy-makers and programme managers the importance of FCs as essential tools for dual prevention. Further, the emergence of new FC products, differing in design and materials, has the potential to lower cost and improve acceptability. There are hurdles in developing new FC products, by far the greatest being the clinical studies required for regulatory purposes. However, several new designs are now available in selected countries and some are progressing through the final stages of regulatory approval, after which they will be more widely available. The new FC designs, which may also be more affordable, will increase options and choice for couples who want to use FCs as their prevention method. Here, we review the FC products that are available now and those still in development which are expected to be available within the next two to five years.
Article
Background To avoid selection bias in clinical trials, random allocation concealment is crucial to ensure that participants and or researchers remain unaware of assignments. Purpose We aimed to design an allocation concealment method that reduced the possibility of selection bias for a randomized, open-label, crossover trial to evaluate device function of four female condom (FC) types. Methods Using scratch card technology, we devised a simple method of concealment, whereby the treatment sequence was printed on a single card for each participant, and the codes for each treatment in the sequence were concealed beneath foil squares on a stiff A6-sized card. On the first and subsequent follow-up visits, the foil corresponding to that visit was scratched from the square to reveal the condom type allocation for the next condom-use period. Staff in the South African and Chinese trial sites were trained in use and care of the card, and on completion of the study completed a questionnaire on their experience of use. Results Research staff in both countries found the card easy to use and those who had previously used the sequentially numbered, opaque, sealed envelopes (SNOSE) system for random allocation reported the scratch card easier to use. Research staff most commonly used a coin to remove the foil square and some used their fingernails. In both South Africa and China, no errors in allocation sequence were found during study monitoring. Limitations Scratch card system of allocation cannot be printed in-house. Conclusions This novel, effective method of concealment for a crossover random allocation was well liked by study staff. The most important advantage of this method is the ability to conceal consecutive allocations of a crossover design using a single card, thus eliminating the need for multiple envelopes per participant. While we used this method in a clinical trial of FCs, it could be employed in a range of other clinical trials and other randomized studies.
Article
The widespread distribution of female condoms (FCs) in developing countries has been hindered by high unit cost, making new less expensive devices a priority for donor agencies. Randomized, crossover study assessing product preference, safety, acceptability and function of three new FCs (PATH Woman's Condom, FC2 and V-Amour) among 170 women in Durban, South Africa. A subsequent "simulated market" study provided participants with free choice of FCs and assessed condom uptake over 3 months. Of the 160 women who used at least one FC of each type, 47.5% preferred the PATH Woman's Condom (WC), 35.6% preferred FC2 and 16.3% preferred V-Amour (p<.001). Women rated the WC better than FC2 and V-Amour for appearance, ease of use and overall fit and better than V-Amour for feel. WC was rated worse than FC2 and V-Amour for lubrication volume. The simulated market demonstrated similar preferences. Total clinical failure rates (i.e., the types of failures that could result in pregnancy or STI) were low (<4%), regardless of condom type. Three new FC types functioned similarly and were generally acceptable. Most participants preferred WC and FC2 over V-Amour, and WC was preferred over FC2 in several acceptability measures.
Article
Male condom functionality studies are typically crossover trials in which enrolled couples use both experimental and latex control condoms for sexual intercourse. Noninferiority of the experimental type is assessed using confidence intervals for differences in breakage and slippage probabilities. Seemingly straightforward, the design, analysis and interpretation of functionality studies are complicated by the choice of noninferiority criterion, study population and the potential for learning effects. Power calculations, secondary data analyses and simulations were used to illustrate concerns and make recommendations. The probability of failure can be too low to draw meaningful conclusions in certain population subgroups. Learning effects among inexperienced users can exaggerate differences in performance and undermine power. A product which is, on average, inferior to latex may still be a viable prophylactic for a large percentage of couples. Heterogeneity of failure probabilities, combined with small acceptable differences in performance, requires care when selecting study participants. Pilot data, adequate training on condom use and reasonable expectations regarding performance of a new condom type are essential to maximizing the chance of identifying a noninferior product.
Article
In addition to a standard slippage and breakage study the United States Food and Drug Administration (USFDA) currently requires a contraceptive effectiveness trial to be carried out as part of the pathway to regulatory approval for new female condoms. In an attempt to explore acceptable alternatives to expensive and resource-consuming Phase 3 contraceptive effectiveness trials the United States Agency for International Development (USAID) recently requested that CONRAD organize a 1-day meeting of investigators in the female condom and semen biomarker fields. The charge to the group was to devise a study design that would validate a biomarker against a biological end point such as pregnancy or a sexually transmitted infection (STI) so that the validated marker could be used to augment a slippage and breakage study for approval of new female condoms eliminating the need for the currently required contraceptive effectiveness trial. The meeting was entitled "Critical Next Steps for Female Condom Research - A Meeting/Workshop" and was convened by CONRAD in Arlington VA on July 8 2008 with USAID support. Afterward a working group of clinical researchers continued deliberations via teleconference and wrote the following report. After exploring the pros and cons of several biological markers prostate-specific antigen (PSA) was identified as the most promising one to pursue for this application because of the extensive previous work involving that marker. (excerpt)
Article
Only one female condom [FC1 Female Condom (FC1)] is currently marketed, but it is poorly utilized, perhaps due to difficulty with insertion, discomfort and suboptimal functional performance during intercourse. The Program for Appropriate Technology in Health (PATH) Woman's Condom (WC) was developed in an effort to overcome these obstacles. This was a randomized crossover study to evaluate the functional performance, safety and acceptability of the FC1 and WC. Seventy-five couples were assigned to one of two condom use sequences (WC/FC1 or FC1/WC) at three centers. Four condoms of the first type were used by couples in four acts of intercourse at home over a 2-4-week period. After a follow-up visit, these procedures were repeated with the second assigned condom type. In a substudy of participants (n=25), a colposcopy was performed prior and subsequent to the first condom use of each of the two condom types. Condom performance was evaluated by calculating measures of function from questionnaires completed by the couple after each condom use. Safety was evaluated by reported urogenital symptoms with a given condom during or immediately following condom use and colposcopic signs of genital irritation in the substudy. Acceptability of each given condom type was measured by questionnaire. Total condom failure (slippage, breakage, etc., divided by the number of female condoms opened) was 31% for the WC and 42% for the FC1. Total clinical failure (slippage, breakage, etc., divided by the number of female condoms used) was 17% for the WC and 24% for the FC1. The proportion of condom failures was 10.9 percentage points less, and the proportion of clinical failure 6.7 percentage points less, when couples used the WC compared to the FC1 [90% CI: -18.5 to -3.3 and -12.6 to -0.8, respectively). Fewer women reported symptoms of urogenital irritation when using the WC vs. the FC1 either overall or when analyzing each use of the condom [woman as unit: -20 percentage points (90% CI: -30.5 to -9.3); condom use as unit: -12.3 percentage points (90% CI: -18.0 to -6.7)]. A similar result was seen for signs of urogenital irritation [woman as unit: -20 percentage points (90% CI: -42.7 to 4.8)]. Among participants with a preference, WC was preferred over the FC1 by twice as many males and by 2.6 times as many females. While both female condoms were safe and acceptable in short-term use, the PATH Woman's Condom leads to less failure, was associated with fewer adverse events, and was more acceptable than the FC1 Female Condom.