Functionality Studies

A critical component of i+solutions' contribution to the UAFC Joint Programme is the female condom functionality studies. These functionality studies support existing and new female condom products by providing suppliers the opportunity to test their products against established norms with the ultimate goal of producing a product which is effective, reliable, easy-to-use and durable. The results of the studies can then be incorporated into product dossiers prepared by manufactures to secure regulatory approvals, particularly WHO/UNFPA prequalification.

The support is deemed critical by UAFC as it has the potential to help new female condoms enter the market, with the ultimate aim of creating a female condom market with a variety of products which are available at affordable prices.

MatCHFunctionality Study I

The first functionality study was undertaken in 2011-2012 and carried out by MatCH (Maternal Adolescent and Child Health) of the University of The Witwatersrand, South Africa. The trial aimed to assess the functional performance (breakage, slippage, invagination and misdirection) and safety of three new condom types — the Woman’s Condom, the VA worn-of-women (VA w.o.w.) Condom Feminine, and the Cupid1 female condom — against the widely available WHO/UNFPA prequalified female condom from the Female Health Company; the FC2.

This randomised controlled, crossover trial was carried out in China and South Africa. The 600 women who took part in the trial were aged 18–45 years, sexually active, monogamous, not pregnant, not allergic to condoms, using another reliable, non-barrier method of contraception, and had no visible or reported sexually transmitted infections.  Women were asked to use five of each female condom type and were interviewed after use of each type. We also assessed safety data for each type. In total 572 women completed  all their follow-up visits,  and these women  used at least one female condom of each of the four  female condom types in the study.

Total female condom failure was 3.43% for FC2, 3.85% for the Woman’s Condom, 3.02% for VA wow and 4.52% for Cupid. Total clinical failure was 2.88% for FC2, 3.05% for the Woman’s Condom, 2.49% for the VA w.o.w., and 3.87% for the Cupid. Non-inferiority was demonstrated for all condom failure modes for the three female condom products in the trial (within the margin of 3% difference in mean failure),  meaning the three assessed female condom products are non-inferior to the FC2 regarding performance and safety.

Cupid1

VA w.o.w.Woman's CondomFC2

(the Cupid1, the VA w.o.w. and the Woman's Condom were tested against the widely available WHO/UNFPA prequalified FC2 (far right).

 

Interpretation

This has been the largest and most comprehensive functionality trial to date and has provided important function data for these devices and has been used to compile evidence for WHO/UNFPA prequalification. Because of this trial, the Cupid condom has already been approved by WHO/UNFPA and is available for public sector procurement. Manufacturers of the other female condom products are using these data in their ongoing applications to regulatory authorities. Access to various female condom products could improve choice for women in need of a contraceptive method that offers dual protection against unintended pregnancy and sexually transmitted infections, including HIV.

Results

The results of the study were published in Lancet Global Health in September 2013.

In the latter, colleagues from the Division of Epidemiology, College of Public Health, Ohio State University, discuss the likelihood that the public-sector procurement of new female condom designs will improve uptake.

 

Functionality Study II

UAFC supported a second functionality study in which two new female condom models were tested against the FC2 as the benchmark. The results of the functionality study form part of the product dossier submitted for application of WHO/UNFPA prequalification. The results of the Functionality Study 2 were submitted to the UNFPA in September 2014. 

Background

The objectives of this research were to assess functional performance, safety and acceptability of the Velvet (HLL) and Cupid2® female condoms. The target population was 300 urban women from Durban (South Africa), aged 18-45 who were either novice or experienced users of FCs. 

Conclusion

Total clinical failure including clinical breakage, invagination, misdirection and slippage was below 5% for all FCs:  FC2 (4.50%), Cupid2 (4.79%)  and HLL (3.93%). While individual failure rates varied slightly by condom type, the two new condoms (Cupid2 and HLL) evaluated in this study were non-inferior to the reference condom (FC2) within a 3% margin.  

To access the full report, click here.

 

Funtionality Studies Citations

Beksinska M, Piaggio G, Smit J, Wu J, Zhang Y, Pienaar J, Greener R,  Zhou Y, Joanis C. Performance and safety of the second-generation female condom versus the Woman’s, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial. Lancet  Global Health  2013; Sept 1: e146–52

Beksinska M, Smit J, Greener R,     Piaggio G, Joanis C. The Female Condom Learning Curve: Patterns of Female Condom Failure Over 20 Uses.  Contraception  2015;91(1):85-90. doi: 10.1016/j.contraception.2014.09.011

Beksinska M, Greener  R, Kleinschmidt I, Pillay L, Maphumulo B, Smit J. A Randomised Non-Inferiority Crossover Controlled Trial of the Functional Performance and safety of New Female Condos: an evaluation of the Velvet, Cupid2 and FC2.   Epub Contraception