Abstract
Objectives
New designs of female condoms have been developed to lower cost and/or improve acceptability.
To secure regulatory approvals, clinical studies are required to verify performance.
We aimed to assess the functional performance and safety of two new female condom
types — Velvet and Cupid2 female condom — against the existing FC2 female condom.
Study design
This was a three-period crossover, randomized noninferiority clinical trial with 300
women randomized to condom-type order in one South African site. Primary end points
were total clinical failure and total female condom failure. Noninferiority of component
modes, clinical breakage, nonclinical breakage, slippage, misdirection and invagination
were also determined. Safety data were also assessed for each female condom. Participants
were asked to use five of each female condom type and to collect information on use
in a condom diary at home and were interviewed after use of each type. Frequencies
and percentages were calculated by condom type for each failure mode, and differences
in performance of the three female condoms using FC2 as reference, with 95% confidence
intervals, were estimated using generalized estimating equation models.
Results
A total of 282 (94%) participants completed follow-up, using at least one condom of
each type. Total clinical failure (clinical breakage, invagination, misdirection,
slippage) was <5% for all female condoms: FC2 (4.50%), Cupid2 (4.79%) and Velvet (3.93%). Noninferiority
was demonstrated for all condom failure modes for the two new female condoms with
respect to FC2, within the margin of 3% difference in mean failure, at the 5% significance
level.
Conclusion
Noninferiority for the two new female condoms was demonstrated with respect to the
marketed FC2. These data are used to support manufacturer dossiers for World Health
Organization (WHO)/United Nations Population Fund (UNFPA) prequalification.
Implications
Data from this study have been submitted to WHO/UNFPA and will contribute to the prequalification
submission requirements for the Cupid2 and Velvet female condoms.
Keywords
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Article info
Publication history
Published online: May 19, 2015
Accepted:
May 14,
2015
Received in revised form:
May 1,
2015
Received:
February 2,
2015
Footnotes
☆There are no conflicts of interest known to the authors.
☆☆This study was funded by the Universal Access to Female Condoms Joint Programme, The William and Flora Hewlett Foundation, and Cupid Ltd.
★This trial is registered on the South African Clinical Trials database DOH-27-0113-4272.
Identification
Copyright
© 2015 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
