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ABSTRACT: 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.
Reproductive health matters 12/2012; 20(40):188-96. · 1.43 Impact Factor
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ABSTRACT: Female condom (FC) failure (breakage, slippage, invagination and misdirection) declines with user experience. Participants in FC performance trials are commonly novice users, and failure rates may be inflated related to inexperience.
This was a randomized, crossover study assessing preference, safety, acceptability and function of three new FCs (WC, FC2 and V-Amour) among 170 women in Durban, South Africa. FC failure by condom type use period was investigated in women using five FCs of each type.
Of the 2411 condoms used during intercourse, 96 failures (breakage, slippage, invagination and misdirection) occurred in 86 condoms (77 condoms had one failure, 8 condoms had two failures, and 1 condom had three failures). Total clinical failure was comparable across FC types. The number of failures in the first condom use period was 58 (7.0%), and this decreased to 21 events (2.6%) in the second and, finally, 17 (2.1%) in the last condom use period. No failures were reported in the last use of the FC in the final condom use period.
FC failure rates decreased markedly after use of the first five condoms, regardless of FC type, and stabilized in the second and third use periods. Consideration should be given to the number of condoms used in trials to ensure that failure rates are not inflated by limiting the numbers of condoms used by novice users.
Contraception 01/2012; 86(2):127-31. · 2.72 Impact Factor
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ABSTRACT: Male condoms are readily available and affordable in many settings, but risky sexual acts still go unprotected.
This unblinded randomized trial, conducted in Ghana, Kenya and South Africa, was designed to assess the impact of providing a choice of condoms on self-reported use and uptake over 6 months.
We enrolled 1,274 men. The mean subject-specific proportion of protected acts with all partners increased from baseline to 6 months by 0.07 in the control group compared to 0.03 in the choice group (p=.025). The observed results were largely consistent across all three countries. In the choice group, men clearly preferred one condom type over the others, and this preference was consistent across all three countries.
Providing one type of male condom in public sector programs appears justified. Programs should not focus on the number of brands available, but should encourage effective promotion and consistent and correct use of available brands.
Contraception 09/2011; 84(3):291-8. · 2.72 Impact Factor
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ABSTRACT: Like male condoms, female condoms (FCs) provide protection against unplanned pregnancy and most sexually transmitted infections including HIV. The first FC made by the Female Health Company was approved by the US Food and Drug Administration (USFDA) in 1993. Since 2000, several different types of FCs have become available or are in development to lower the cost and/or improve acceptability. Although similar in function, new FCs often differ in design and materials. Classified as Class III medical devices by the USFDA, FCs have a regulatory process that is more complex than that for male condoms. This, coupled with the lack of an international standard to verify the quality of new devices, has hindered new products gaining regulatory approvals and entering the market. We review the existing regulatory pathway for FCs, the progress made in developing standards specifically for FCs and the FCs available now or in development, including their current status regarding approval.
Contraception 04/2011; 83(4):316-21. · 2.72 Impact Factor
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ABSTRACT: 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.
Contraception 03/2011; 83(3):248-54. · 2.72 Impact Factor
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Contraception 06/2009; 79(5):339-44. · 2.72 Impact Factor
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ABSTRACT: Definitions of male condom failure modes are now well documented, and failure events are usually reported as the proportion of the total number of condoms used and the proportion of men/couples who experience an event. The lack of standardized definitions for female condom (FC) failure has led to variability in reporting and hence difficulties in making comparisons across studies. As a result, the World Health Organization convened a technical review committee meeting in January 2006 through which the members compiled and agreed to a standard list of terms and definitions for each of the failure modes. These failure modes apply to FCs currently marketed or in advanced stages of clinical testing. They were designed to assist in the review and comparative assessment of different FCs.
Contraception 05/2007; 75(4):251-5. · 2.72 Impact Factor
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ABSTRACT: This multisite, randomized, crossover trial comparing the performance of the Reality female condom (FC1) with a new synthetic latex prototype (FC2) was conducted in Durban, South Africa.
In total, 276 women were enrolled and 201 women completed the study. Altogether, 1910 FC1 condoms and 1,881 FC2 condoms were used.
Total breakage was 0.73% in FC1 and 0.85% in FC2 (95% confidence interval, -0.64 to 0.87). The number of clinical breakages (those that could result in a pregnancy or sexually transmitted infection) was similar for each condom type (FC1, n=9; FC2, n=8). Incorrect penetration (penis between condom and vaginal wall) was 1.26% and 0.64% for FC1 and FC2, respectively. Outer ring displacements (outer ring pushed into the vagina partially or fully) were comparable for both condoms (FC1, 3.14%; FC2, 2.98%). Slippage (condom came out of the vagina) was rare and reported in 0.37% or less of devices used. Total clinical failure was 5.24% in FC1 and 4.3% in FC2.
The FC1 and FC2 performed comparably within this trial.
Contraception 05/2006; 73(4):386-93. · 2.72 Impact Factor
