A randomised trial has shown that three new models of female condom are non-inferior to the established model, leading the authors to suggest that the new products could be made more widely available, increasing the range of prevention options available to women. An open-access article reporting on breakage and slippage is published in the September issue of Lancet Global Health, with acceptability data having been presented to a conference earlier in the year.
The first model of female condom, FC1, sometimes marketed as Femidom or Reality, was introduced in 1993. An improved model that is softer and less noisy, as well as much cheaper to produce – known as FC2 – was approved by United Nations agencies in 2007 and US regulators in 2009.
But female condoms remain under-used, with international donors distributing around 140 male condoms for each female condom that they provide. A number of barriers have been identified – cost (around $0.60 each, compared to $0.03 for a male condom); few studies to demonstrate their effectiveness against infections; minimal support from policy makers; inconsistent distribution and promotion; low awareness amongst women and their partners; and little variety in the design of a product that can be difficult to use at first.
Responding to the last issue, several new models have been developed, with this study evaluating the Woman’s Condom (developed by the non-profit organization PATH), the VA wow condom (Medtech Products, India) and the Cupid female condom (Cupid, India), in comparison with FC2 as the ‘standard of care’.
While each has some unique design features, there are many similarities. Each comprises a soft, flexible sheath that lines the vagina and may partially cover the external genitalia. In order to hold the condom in place, devices variously have an internal ring, a foam sponge or small dots of soft foam which gently adhere to the interior of the vagina. To make insertion easier, the Woman’s Condom is held together by a rounded cap which dissolves once it is put in place. Each device has some sort of external ring or frame which prevents the condom from being pushed inside the vagina and which aids removal.
The different condoms are made variously of natural latex, synthetic rubber or polyurethane. With one exception, all are pre-lubricated.
Researchers recruited 272 women in Durban, South Africa and 300 women in Shanghai, China. Participants were generally well educated. Almost all the Chinese women were living with a partner, whereas only a minority of the South African women were. While 14% of the South African women had previously used a female condom, none of the Chinese women had.
Each woman was asked to use each type of condom five times each, but was randomised to a group testing the condoms in a different sequence. Diaries and interviews were used to gather data on failure rates and acceptability.
This was a ‘non-inferiority’ trial – in other words, the researchers aimed to verify that the new models were not worse than FC2. Similarly, FC2 was approved by regulators on the basis of data showing that it was non-inferior to FC1 in terms of failure.
Regarding condom failure, the researchers asked about the devices tearing or breaking; slipping out of the vagina; the penis being inserted between the condom and the vaginal wall; and the external ring or frame being pushed inside the vagina.
On each measure, rates were low, and generally did not differ significantly from FC2, with all being found to be non-inferior to FC2 (within a margin of 3%). Overall condoms failed on around 3 in every 100 occasions – 2.9% for FC2, 3.1% for the Woman’s Condom, 2.5% for VA wow and 3.9% for Cupid. (Similar, and often higher, failure rates have been reported for male condoms.)
Failure rates were similar in South Africa and China, reinforcing the validity of the results.
Less than 1% of women reported adverse events such as vaginal pain, penile itching or rash.
In terms of acceptability, data are only available from the South African participants. Individual women expressed different preferences for different models, and some devices were better rated for some features than for others, but overall scores were consistent, with all new models at least as acceptable as FC2.
In terms of feel and sensation, 91.2% of women ‘liked somewhat’ or ‘liked very much’ the Woman’s Condom, 90.8% did so for Cupid, 88.2% for FC2 and 83.8% for VA wow. Similarly, each scored over 80% for its appearance; over 85% for its length, lubrication and scent; and over 90% for its colour.
In terms of ease of use over 85% of women ‘liked somewhat’ or ‘liked very much’ each model. However, scores for ease of insertion were lower – over 60% for each device, except for VA wow which scored 48.5%.
The investigators report that manufacturers of the devices are using these results in their applications to regulatory authorities. The Cupid condom has been approved (pre-qualified) by the World Health Organization (WHO) and the United Nations Population Fund (UNFPA). It is already available in South Africa, Mozambique, Indonesia, India, and other countries, and with a unit price of $0.35 it is cheaper than FC2.
US investigators are completing analysis of an observational study assessing the Woman’s Condom effectiveness in preventing pregnancy. Moreover, the failure rate of the condom will be assessed not only by self-report, but by testing vaginal samples for prostate-specific antigen (PSA), a biomarker for exposure to semen. If supportive, these study results may lead to approval by the Food and Drug Administration (FDA) in the United States, as well as WHO/UNFPA.
More data on the products’ effectiveness in preventing pregnancy and infections may be important in strengthening policy makers’ support for female condoms.
The investigators believe that a greater choice of models for women and their partners may lead to improved uptake and more consistent use of female condoms, resulting in fewer infections and unwanted pregnancies.
Beksinska ME et al. 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. Lancet Global Health 1(3): e146-152, 2013. (Click here for free, full text.)
Beksinska ME et al. Acceptability of New Female Condom Designs Among Women Attending an Urban Reproductive Health Clinic in Durban, South Africa. First Global Conference on Contraception, Reproductive and Sexual Health, abstract P178, Copenhagen, May 2013. (Click here for the abstract.)