1. Two new female condoms, Velvet and Cupid2, were demonstrated to be non-inferior to the currently marketed FC2 female condom.
2. All 3 condoms were highly effective, with clinical failure rates less than 5%.
Evidence Rating Level: 1 (Excellent)
Study Rundown: In 2011, the Reproductive Health Supplies Coalition, a global partnership that advocates for reproductive health options, identified the female condom as an under-utilized reproductive health technology. While female condoms have been growing in popularity over the past decade—from 2007 to 2012 distribution increased from 25 million units to over 60 million units—their use still pales in comparison to the popularity of male condoms. Female condoms represent only 0.19% of global condom use. With a similar efficacy to male condoms, female condoms also come with the notable advantage of providing women with the agency to practice safe sex. Currently there are only 2 female condoms that are pre-qualified by the WHO and UNFPA—the FC2 and Cupid. In this study, researchers compared safety and efficacy of two new female condom designs—the Velvet and Cupid2—to the FC2 in a non-inferiority trial.
All 3 condoms were highly effective with failure rates of under 5%; both the Cupid2 and the Velvet were non-inferior to the FC2. Unlike male condoms, new female condoms are required to demonstrate functionality in a clinical trial prior to approval–this data will be submitted to the WHO/UNFPA and will contribute to the application for pre-qualified status for the Cupid2 and Velvet. Strengths of this study include the rigorous study design and high retention rate—94% of women used at least 1 of each condom type. Data was exclusively self-reported and participants were not blinded due to noticeable differences in the condom designs, which are both limitations. Studies with long-term follow-up data might investigate objectively measured clinical outcomes, such as pregnancy or sexually transmitted infections, to further assess efficacy.
In-Depth [randomized non-inferiority trial]: In a 3-period crossover, 300 South African women were asked to use 5 each of 3 female condoms—the currently available FC2 and 2 new models, Velvet and Cupid2. Participants were randomized to condom type order and asked to report information in a home diary as well as in post-use interviews. The primary outcome was self-reported total clinical failure (breakage, invagination, misdirection, slippage). The margin of non-inferiority was defined as 3% difference.
Total clinical failure was <5% for all condom types—FC2 (4.50%), Cupid2 (4.79%), Velvet (3.93%). There was no significant difference in failure rates between the Cupid2 and Velvet and the FC2—both were within the margin of 3% difference required to be considered non-inferior. The Cupid2 had a higher average of misdirection events in which the condom failed to consistently protect mucosal surfaces (25 vs. 16, p = 0.026).
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