The following ongoing studies on cervical barriers and internal/female condoms are listed in reverse chronological order based on the start date of the study.
These listings are updated annually. Help us keep the list complete and up to date!
If you have updated information for a study below or know of research that is not included, please email us: info@cervicalbarriers.org.
Internal/Female Condoms
Condom Perceptions Study
Location: South Africa
Male/external and female/internal condoms are the only available multi-purpose technology (MPT) that provides triple protection, preventing unintended pregnancy and sexually transmitted infections, including HIV.
Rebranding has been shown to be an effective demand-creation strategy for the male condom. Launched in 2015, the Max external/male condom is now available in four different scents. The internal/female condom has undergone similar branding and is now available as “Maxima.”
Now that the rebranded Max/Maxima condoms have been available for several years it is important to evaluate how these and other brands of condoms are perceived, accessed, and used. The aim of this study is to evaluate male and female youth condom perceptions with a focus on the perceptions of the Department of Health branded Max/Maxima condoms. A national survey will be conducted using an on-line anonymous survey with youth aged 16-35 (male and female) distributed as a link via permissions from collaborating organisations.
This study is being conducted by MaTCH Research Unit and funded by UNFPA South Africa.
Data collection has concluded and an internal report has been completed.
Internal/Female Condom Colour Preference Study
Location: South Africa
Although coloured and scented external/male condoms have been available globally for many years, internal/female condoms have not been available in different varieties until 2019. The Female Health Company, manufacturer of the FC2 female condom, introduced the strawberry scent (red), vanilla scent (purple) and caramel (brown) globally and in South Africa in 2019 the strawberry and vanilla varieties became available. Cupid Limited introduced strawberry and vanilla internal/female condoms globally in 2019. Colleagues from MaTCH Research Unit are conducting a secondary analysis of choice of scent/colour of female condoms when female condom users are offered the natural, strawberry, and vanilla in a female condom study. Women can choose to take one or a combination of any of the available colours (FC2: plain, strawberry, or vanilla) and Cupid (plain or strawberry). Woman make their initial choice at the baseline visit and subsequently at follow-up visits can change to different varieties. A manuscript has been submitted for publication.
Female Condom Contraceptive (CoCo) Study
Location: South Africa
This randomized comparative prospective follow-up study aims to evaluate contraceptive effectiveness of the Cupid, Cupid 2 and FC2 female condoms. The contraceptive effectiveness will be determined for 6 months. Target enrolment is 780 volunteers. The volunteers will be followed-up monthly for up to seven months. A daily diary will be used to record menstrual pattern, acts of intercourse and details of condom usage. The primary endpoint will be the occurrence of pregnancy or use of emergency contraception, and the diary information will allow pregnancy rates to be characterised by patterns of condom use and failures (contraceptive efficacy and effectiveness rates). The study commenced enrolment in November 2019, but data collection was delayed due to COVID-19. Data collection was completed in October 2021. Data cleaning and analysis are underway. Funding was provided by Female Health Company and Cupid, Ltd.
A Functional Performance Study of the Wondaleaf Female Condom
Randomized crossover trial
Location: South Africa
Background: The Wondaleaf female condom is a new female condom (FC) design made of polyurethane with no external or internal rings. The body of the condom is fitted by an exterior adhesive shield (figure 1) which also displays the condom when removed from the condom packaging.
Purpose: To ascertain the functional performance of the Wondaleaf FC.
The primary objective was to ascertain the functional performance of the Wondaleaf FC with primary endpoints of total clinical failure and total device failure. The secondary objectives were to gather acceptability and safety data (as determined by the number of adverse events) on each FC type.
220 women were enrolled, of whom 210 completed the study using both Wondaleaf FCs and FC2 female condoms (available in the South African public sector). The study was completed in October 2019 and results showed the Wondaleaf condom was non-inferior to the FC2. An article is in preparation for submission.
A Functional Performance Study of the Woman’s Condom 2: An adapted design of the Woman’s Condom
Randomized controlled study
Location: South Africa
This project evaluated the functional performance of the adapted Woman’s Condom design (WC2) without the foam dots.
Objectives: We aimed to assess the functional performance and safety of a modified Woman’s Condom (WC2) against the existing FC2 female condom.
Study design: This randomized clinical trial enrolled 287 women in one South African site. The primary outcome of the study was the rate of female condom failure. Participants were asked to use five of each female condom type and to collect information on use in a condom log at home and were interviewed after use of each FC type.
Publications
Beksinska M, Greener R, Mphili N, Smit J, Kilbourne-Brook M, Coffey PS. Functional performance study of an adapted design of the woman’s condom: a crossover, noninferiority, randomized clinical trial. Eur J Contracept Reprod Health Care. 2019;24(3):233–239. doi:10.1080/13625187.2019.1610940
Funder/Sponsor: PATH and UAFC
Principal Investigators: Dr M. Beksinska and Prof J. Smit
Sites: Commercial City Site
Performance and failure mode study comparing the Woman’s Condom and the FC2 female condom, and using prostate-specific antigen as a biomarker of semen exposure
Randomized crossover study
Location: United States
This study is a randomized crossover study comparing self-reported clinical failure rates among 330 couples using the Woman’s Condom and the FC2 female condom. The secondary objects are: to compare the ability of the Woman’s Condom and the FC2 to prevent vaginal exposure to semen, as indicated by detection of PSA within the vagina; to calculate the sensitivity and specificity of reported failures for the presence of semen, using PSA as the indicator of the presence of semen; and to compare acceptability of the Woman’s Condom and FC2.
The clinical portion of this study was completed in 2011. The statistical report has been submitted to the FDA. A manuscript presenting study results is in process.
This study was implemented by California Family Health Council; CONRAD is the regulatory sponsor.
Related publications:
Mauck et.al. Critical next steps for female condom research – report from a workshop. Contraception. 2009 May;79(5):339-44.
Woman’s Condom safety and contraceptive efficacy study
Contraceptive effectiveness study
Location: 10 research sites in the United States
Begun in 2011, this is a multi-center, open-label, non-comparative study testing the safety and efficacy of the Woman’s Condom among 450 women recruited from 10 research centers in the United States. Participants agreed to use the Woman’s Condom as their primary contraceptive method for 6 months. A subset of women participated in a sub-study using prostate specific antigen (PSA) as a biomarker of semen exposure. These PSA data will be compared to PSA data collected as part of the CONRAD comparative performance and failure mode study (see previous entry), to build evidence of the sensitivity and specificity of PSA to measure female condom failures.
The clinical portion of this study was completed in late 2012, and data analyses are underway. The clinical study report is being drafted for FDA review.
This study was implemented by NICHD; CONRAD is the regulatory sponsor.