Comparative crossover study of the PATH Woman's Condom and the FC Female Condom.

Abstract

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.

Full text

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Original research article
Comparative crossover study of the PATH Woman's Condom and the FC
Female Condom®
Jill L. Schwartza,⁎, Kurt Barnhartb, Mitch D. Creininc, Alfred Poindexterd, Angie Wheelesse,
Maggie Kilbourne-Brookf, Christine K. Maucka, Debra H. Weinere, Marianne M. Callahana
aDepartment of Obstetrics and Gynecology, CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA
bDepartment of Obstetrics and Gynecology and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania,
Philadelphia, PA 19104, USA
cDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh and Magee-Women's Research Institute,
Pittsburgh, PA 15213, USA
dAdvances in Health, Inc., Houston, TX 77030, USA
eFamily Health International (FHI), Research Triangle Park, NC 27713, USA
fProgram for Appropriate Technology in Health (PATH), Seattle, WA 98107, USA
Received 7 May 2008; revised 18 July 2008; accepted 18 July 2008
Abstract
Background: 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.
Study Design: 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.
Results: 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.
Conclusions: 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.
© 2008 Elsevier Inc. All rights reserved.
Keywords: Female condom; PATH Woman's Condom; Reality®, FC Female Condom®; Slippage; Breakage
1. Introduction
The Reality® Female Condom (currently called FC
Female Condom®)(FC1;Female Health Company,Chicago,
IL, USA) was approved by the US Food and Drug
Contraception 78 (2008) 465–473
⁎Corresponding author. Tel.: +1 703 524 4744; fax: +1 703 524 4770.
E-mail address: jschwartz@conrad.org (J.L. Schwartz).
0010-7824/$ – see front matter © 2008 Elsevier Inc. All rights reserved.
doi:10.1016/j.contraception.2008.07.020

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Administration (FDA) in 1993 as the first barrier contra-
ceptive for women that offered limited protection against
sexually transmitted infections (STIs). This female condom
has a 6-month typical use pregnancy rate of 12.4 per 100
woman-years in a US population [1], has not been associated
with trauma to the genital tract [2], prevents trichomoniasis
recurrence[3],andmayofferasmuchprotectionfromSTIsas
male condoms [4]. The FC2 has been introduced as an
updated version of this condom using synthetic latex for
greater affordability [5].
Despite global need for a female controlled barrier device,
there has been poor sustained utilization of this method and
the potential impact of the device, as an HIV prevention
strategy has not been fully evaluated. In female condom
studies conducted over the past decade, varying proportions
of users have liked the device and succeeded in using it,
resulting in differing acceptability ratings in short-term
acceptability studies, depending on the study population and
the type of intervention [6–10]. These studies have identified
a constellation of problems with female condom use
including difficulty with insertion, discomfort and subopti-
mal functional performance during intercourse that may
contribute to poor utilization.
The Program for Appropriate Technology in Health
(PATH), a nonprofit, international health organization, has
used an iterative user-driven development process to
produce a novel female condom product in an attempt to
overcome these obstacles. The PATH Woman's Condom
(WC) has a thin, pliable plastic pouch that conforms to the
shape of the vagina, is 9 in. long and has a flexible soft
outer ring that is intended to protect the external genitalia
(Fig. 1). The four oblong foam pieces on the outside of the
pouch are intended to cling lightly to vaginal walls,
ensuring stability of the device. The distal end of the
pouch and foam pieces are packaged into a capsule which
serves as an insertion aid and dissolves quickly when
inserted into the vagina. The PATH Woman's Condom was
easy to use and comfortable in a short-term acceptability
study [11].
This study was designed to further test the functional
performance, safety and acceptability of this novel female
condom and to gain additional information for further
development. This crossover study compared the PATH
Woman's Condom (WC) to the FC1 after four uses of each
condom type by 75 couples.
2. Materials and methods
Seventy-five couples were enrolled between December
2004 and August 2005 in this Phase I, comparative, open-
label, two-period crossover study comparing the WC to the
FC1 at three clinical centers: University of Pennsylvania
Medical Center; University of Pittsburgh/Magee Womens
Research Institute; and Advances in Health, Houston, TX,
USA. The sample size was not selected on the basis of
hypothesis testing. The crossover design was chosen because
between-patient variation can be eliminated, and smaller
groups can be used.
Couples who agreed to participate were in good health, at
least 18 years old, and at low risk for HIV or STIs. Those
couples at risk for pregnancy used a steroidal contraceptive
(oral, patch, injectable or implantable) or sterilization
(vasectomy or tubal ligation) throughout their participation.
Individuals who had sensitivities or allergies to study
products or prior experience with female condoms were
excluded. The protocol and informed consents for this
nonsignificant risk device study were reviewed and
approved by the site institutional review boards.
Informed consent was obtained from each member of the
couple. The female volunteer provided a urine specimen for
a pregnancy test and height and weight were measured.
Volunteers in the colposcopy substudy at the University of
Pennsylvania Medical Center (n=25) also underwent a pelvic
Fig. 1. PATH Woman's Condom.
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examination with Pap smear, if not performed in the past
year; wet mount and Neisseria gonorrhoeae and Chlamydia
trachomatis polymerase chain reaction testing.
Enrolled couples were randomized to one of two condom
use sequences. Participants were given either a WC research
study packet or a FC1 research study packet as determined
by the assigned condom use sequence for the first condom-
use period to use in four separate acts of intercourse over a
2–4-week period. The PATH Woman's Condom (WC)
(PATH, Seattle, WA, USA) isan investigational device that is
not prelubricated. The FC1, a 6.5-inch long polyurethane
plastic pouch with two flexible rings, was used as the control
female condom because it is the only FDA-approved female
condom. Participants were instructed to wait 30–60 s after
inserting the WC to have intercourse to allow for the
insertion capsule to dissolve. A total of four condoms, each
along with a 3-mL package of Astroglide® (BioFilm, Vista,
CA, USA), and instructions for use were distributed. The
couples also went home with a detailed condom use
questionnaire to complete after each intercourse, and an
acceptability questionnaire to be completed separately by
each person at the end of each condom use period. Female
participants had a follow-up visit after completing the four
acts of intercourse, at which time questionnaires and diaries
were reviewed and collected, and second assigned condoms
and questionnaires and diaries were distributed.
Female participants in the substudy underwent a baseline
colposcopy prior to the first condom use of each of the two
condom types. These women were abstinent from using
vaginal products and all sexual activity starting 72 h prior to
the baseline colposcopy until after intercourse with the study
condom. The couples were to use the condom for the first act
of intercourse within 72 h of the baseline colposcopy and the
female participant was to return within 6 h after intercourse.
After intercourse, colposcopy was performed to examine the
immediate effects on the cervicovaginal epithelium of the
foam shapes and insertion capsule components of the WC
and to compare this to the effect of the inner ring of the
marketed FC1, according to the CONRAD/World Health
Organization Manual [12].
This was a single-blinded study with only the clinicians
performing the colposcopies unaware of the participant's
condom assignment. Due to the obvious difference in
condom design, the participants could not be blinded to the
condom type being used. The random permuted blocks
method was used to generate random condom-use sequences
for 25 participants per site. The sequences were created by a
randomization manager using a verified program based on
the random function RANUNI in the SAS® System (SAS
Institute, Cary, NC, USA). Allocations were sealed in
separate individually sealed envelopes identified by partici-
pant number.
The condom performance outcome was measured by
calculating the functional measures (breakage, slippage,
etc.) described in Appendix A from questionnaires
completed by the couple after each condom use. The
primary safety outcomes were the proportion of participants
with urogenital symptoms and the proportion of condom
uses during or immediately after which urogenital symp-
toms were noted. These symptoms included urogenital pain
and discomfort (e.g., burning, stinging or pressure),
dysuria, genital irritation or rash, genital pruritus, abnormal
vaginal discharge, pelvic or lower abdominal pain or
intermenstrual bleeding for the female and urogenital pain
or discomfort and genital irritation or rash for the male
participants. The substudy safety outcome measured the
proportion of female participants with signs of genital
irritation of the external genitalia, cervix and vagina as
observed on colposcopic examination after one act of
intercourse with a given condom type. Adverse events
(AEs) were coded in the MedDRA dictionary based on
blind review of the AE description. Acceptability was
measured for each given condom type by questionnaire.
All statistical analyses were descriptive or involved
calculation of 90% confidence intervals (CIs) about the
event proportions. Generalized estimating equations were
used to model the differences in proportions of condom
failure when couples used the WC versus the FC1,
controlling for center and taking into account clustering of
condom use within couple. In addition, differences in
proportions between the two types of condoms, together
with 90% CIs, were calculated for signs and symptoms of
urogenital irritation. The 90% CI for the difference in
proportions between treatment represents the range of
differences in treatment that cannot be rejected (by a two-
sided test, alpha=.10) given the observed data.
3. Results
Of the 82 couples screened for eligibility, 75 were
enrolled and 73 completed the study (Fig. 2). The
functional performance definitions are detailed in Appen-
dix A. Participant characteristics are described in Table 1.
Participants at the Houston site differed from those at the
other two sites in that they were likely to be older (female
mean=34.3, male mean=35.5), identified themselves as
Hispanic or black more frequently, and were less educated
(female mean=13.2 years, male mean=12.6). They were
also more likely to have had a previous female sterilization
or hysterectomy, weigh more (female mean=172.9), and
have previously been pregnant.
Nine enrolled couples did not open and use all 4 of
either or both condom types. Five couples used all four
WC but only used one to three FC1 because of
discomfort. Three couples used three to four FC1 and
zero to two WC. One couple used only one WC after
which the female participant developed bilateral labial
swelling and erythema and was discontinued early from
the study. Condom use questionnaires were completed for
287 WC uses and for 285 FC1 uses. Of those, four WC
and seven FC1 broke while opening the packages, four
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WC and five FC1 were not inserted, and no vaginal
intercourse occurred for five WC uses and one FC1 use.
Therefore, a total of 274 WC and 272 FC1 were used
during intercourse.
Most condoms were inserted by the female participant
(80%) and in the vagina as per instructions (97%). The study
condoms were worn during vaginal intercourse for an
average of 16 min with a range of 1–93 min.
A greater percentage of FC1 uses compared to WC uses
were associated with difficulty handling the device before
insertion (44% compared to 9%), difficulty placing the
device in the vagina (36% compared to 8%), discomfort
during insertion (21% compared to 8%) and device
instability after insertion (16% compared to 9%). About
one third of uses of each device were associated with
uncertainty as to how deep to place the device (FC1=26.0%,
WC=28.1%) and whether the device was correctly placed
(FC1=29.7%, WC=26.9%).
Total condom failure (Appendix A) was 31% for the WC
and 42% for the FC1 and total clinical failure (Appendix A)
was 17% for the WC and 24% for the FC1 (Table 2). 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) (Table 2). WC leads to significantly less
failure than FC1 with regard to partial turning inside out and
partial slippage and there is a trend toward significance with
complete slippage.
Approximately 44% of the couples during WC use and
53% of couples during FC1 use experienced at least one
event that contributed to total clinical failure. A minority of
couples experienced clinical breaks (4% and 0%, for WC and
FC1, respectively) or complete slippages (6% and 8%, for
WC and FC1, respectively).
The most common failure type contributing to clinical
failure was outer ring displacement which was 9.9% for both
condom types (Table 2). Approximately 21 couples (29%)
experienced at least one outer ring displacement during WC
use compared to 17 couples (23%) during FC1 use. Nine
couples reported outer ring displacement with at least one
use of both products.
Couples used lubrication for the WC in 91% of condom
uses and for the FC1 in 61% of condom uses (the FC1 is
prelubricated). When asked about the relationship of
condom failure to lubricant, 24 (41%) out of 59
respondents who reported a failure (turned inside out,
slipped out and/or pulled out) with the WC felt that it was
Table 1
Participant characteristics
Female (n=75)Male (n=75)
n%n%
Age (years)
Mean±S.D.
Range
Ethnicity
Hispanic
Not Hispanic
Race
Asian
Black or African American
White
More than one race
Other
Education
Mean±S.D.
Ever used
Oral contraceptives
Male condom
Female condom
Diaphragm
Primary method
Tubal ligation
Oral contraceptives
Hormonal injection
Hormonal patch
Othera
Height (in.)
Mean±S.D.
Range
Weight
Mean±S.D.
Range
Ever pregnant
Yes
Current relationship with male partner
Living together
Length of time with male partner (years)
Mean±S.D.
Range
29.2±8.3
19–60
30.7±8.5
19–58
13
62
17
83
13
62
17
83
3
15
55
2
0
4
20
73
3
0
11
15
56
20
75
3
1
2
1
14.9±2.5 14.9±2.7
70
73
0
3
93
97
0
4
9
46
8
6
6
12
61
11
8
8
64.2±2.5
59–72
153.1±33.8
110–260
3445
41 55
5.5±6.8
0.3–40
aOther methods used while in study include: hysterectomy, post
menopausal, and vaginal ring.
Fig. 2. Flow diagram of study.
468 J.L. Schwartz et al. / Contraception 78 (2008) 465–473

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related to lubrication. Likewise, 40 (46%) of 87 respon-
dents who reported a failure with the FC1 condom felt that
it was related to lubrication. The most common reasons
given for the failure of both condom types were that there
was not enough lubricant and that the lubricant was dried
out or sticky.
Men ejaculated during 228 of the 274 WC uses (83%) and
during 205 of the 272 FC1 uses (75%). Most of the study
condoms had to be pulled gently for removal; however, over
a third were pulled straight out without twisting to remove
which may account for the semen spillage reported in about
7% of the WC and FC uses.
Condom failure rates for all types of failure were higher
during the first condom use period compared to the second
condom use period, regardless of condom type.
Types of urogenital symptoms are listed in Table 3.
Fewer women reported symptoms of urogenital irritation
when using the WC versus the FC1 either overall (e.g.,
taking the woman as the unit of analysis) or when
analyzing each use of the condom [woman as unit: −20
percentage points (90% CI: −30.5 and −9.3); condom use
as unit: −12.3 percentage points (90% CI: −18.0 and
−6.7)]. Five women had at least one AE with both condom
types. One participant had bilateral labial swelling and
Table 2
Condom functionality
PATH WC (n=287)FC1 Female Condom (n=285)WC-FC 1
n% 90% CIn%90% CI Difference 90% CI
Total number of condoms openeda
Broke while opening
Broke during insertion
Broke other (capsule off or missing)
Total number of condoms usedb
Broke during intercourse
Don't know when
Type of failurec
Clinical breakage
Nonclinical breakage
Total breakage
Incorrect penetration
Pullout
Complete turning inside out
Partial turning inside out
Complete slippage
Partial slippage
Outer ring displacement
Total clinical failured
Total condom failured
287 100.0
1.4
0.0
0.7
95.5
0.7
0.4
285100.0
2.5
0.7
0.0
95.4
0.0
0.0
4
0
2
7
2
0
274 272
2
1
0
0
3
6
9
6
1.1
2.1
3.1
2.2
13.5
0.7
4.4
1.5
10.6
9.9
17.2
31.0
0.3–2.8
0.9–4.1
1.7–5.4
1.0–4.3
10.2–17.4
0.1–2.3
2.6–7.0
0.5–3.3
7.7–14.2
7.1–13.3
13.5–21.3
26.5–35.8
0
9
9
7
0.0
3.2
3.2
2.6
17.3
0.4
9.6
3.7
15.4
9.9
23.9
42.1
0.0–1.1
1.7–5.5
1.7–5.5
1.2–4.8
13.6–21.5
0.0–1.7
6.8–13.0
2.0–6.2
12.0–19.5
7.1–13.4
19.7–28.5
37.2–47.1
–
−1.1
0.1
−0.2
−1.9
0.4
−4.6
−2.1
−5.1
−0.4
−6.7
−10.9
−3.0 to 0.8
−2.1 to 2.3
−2.0 to 1.7
−6.7 to 2.9
−0.7 to 1.3
−8.3 to −0.8⁎
−4.2 to 0.0
−9.6 to −0.7⁎
−4.5 to 3.8
−12.6 to −0.8⁎
−18.5 to −3.3⁎
37
2
12
4
29
27
47
89
47
1
26
10
42
27
65
120
aDenominator for nonclinical breakage, total breakage and total failure.
bDenominator for clinical breakage, incorrect penetration, pullout, complete turning inside out, partial turning inside out, complete slippage, partial
slippage, outer ring displacement and total clinical failure.
cA condom may be counted for more than one type of failure.
dA condom only contributed to total failure or clinical failure once, even if it had more than one type of failure.
⁎Since the upper bounds of these CIs do not include 0, there is a difference (p≤.10, two-tailed) between condom types.
Table 3
Urogenital symptoms
Adverse eventPATH Woman's Condom n=73FC1 Female Condom n=74
Number of eventsNumber of women (%) Number of events Number of women (%)
Genital pain
Genital discomfort
Genital rash
Pelvic pain
Labial swelling
Intermenstrual bleeding
Genital pruritus
Vaginal candidiasis
Dysuria
Total number of events/women with at least one eventa
8
7
2
0
1
0
0
1
0
6 (8%)
4 (5%)
1 (1%)
0
1 (1%)
0
0
1 (1%)
0
9 (12%)
30
25
0
6
0
1
1
1
3
67
13 (18%)
10 (14%)
0
4 (5%)
0
1 (1%)
1 (1%)
1 (1%)
3 (4%)
24 (32%)19
aWC-FC1 difference (90% CI) for condom as a unit: −12.3 (−18.0 to −6.7) and for women as a unit: −20.0 (−30.5 to −9.3). Since the upper bounds of these
CIs do not include 0 there is a difference (p≤.10, two-tailed) between condom types.
469J.L. Schwartz et al. / Contraception 78 (2008) 465–473