The following ongoing studies on cervical barriers and female condoms are listed in reverse chronological order based on the start date of the study.
Randomized, parallel double-blind Phase I study
The purpose of this study was to evaluate the safety of ContraGel versus the HEC Universal Placebo gel when used with the Caya diaphragm during two 7-day periods of daily use. During the first 7-day period, the participant abstained from intercourse and during the second 7-day period, she engaged in two acts of intercourse.
Safety was assessed by adverse events (AEs), colposcopy, vaginal pH, microflora, anti-microbial activity and soluble markers of inflammation in the cervicovaginal fluid (CVF); and epithelial integrity, and immune cell phenotype and activation status in genital tissue.
This study aimed to enroll up to 24 healthy premenopausal women protected from pregnancy by female sterilization. Participants were randomized in a 1:1 ratio to insert the SILCS diaphragm used with either Contragel or the HEC Universal Placebo gel every day for two 7-day periods in two separate menstrual cycles.
This study was implemented by CONRAD at the Eastern Virginia Medical School, and funded by USAID.
Under the Expanding Effective Contraceptive Options (EECO) project, Population Services International (PSI) and its Zambian subsidiary, the Society for Family Health (SFH), registered and launched the new Maximum Diva brand Woman’s Condom (MDWC) in Zambia in February 2016. Researchers are using a randomized evaluation to measure the impact of an interpersonal communication (IPC) program—which are person-to-person or small group interactions aimed at increasing the sharing of information, feelings and experience—on self-reported knowledge, acceptability, and use of condoms in the context of the mass distribution and mass marketing campaign of the MDWC.
A baseline survey was conducted prior to the MDWC distribution and launch of the supporting marketing campaign. Researchers will randomly assign 40 wards in Lusaka to either receive an IPC program or serve as the comparison group (20 wards each). Local young people recruited and trained in IPC interventions will set up information booths in central market areas in each intervention ward, and go door to door, in order to organize groups of young people to participate in the IPC sessions. These IPC sessions will occur over a 6 month period.
Researchers will measure the impact of the IPC intervention by comparing outcomes in wards that receive the program to wards in the comparison group that do not receive the program. To measure the impact of this intervention, researchers will compare overall condom use, use of the female condom, and willingness to use a female condom between comparison and IPC wards. They will also non-randomized methods to measure the effect of the distribution and mass media campaign on contraception knowledge, attitudes and practices.
Data collection is underway with results expected in Spring 2017.
This project is being funded by a two year grant from USAID.
Location: South Africa
Related publications and presentations:
Beksinska ME, Nkosi P, Kubeka M, Smit JA, Mabude Z, Mantell JE, Greener R, Phungula L,
Marumo E, Chidarikire T, Rodríguez H. Who has heard of or ever used the female condom in South Africa? The National Female Condom Evaluation in South Africa. Poster presented at 21st International Aids Conference; 2016 July 18-22; Durban, South Africa.
Mabude Z, Beksinska M, Mantell JE, Nkosi P, Mnguni N, Greener R, Smit J, Jacobson L. “Will he let me use a female condom? Will sex be the same?” Attitudes and experiences of female condom users attending selected public-sector health facilities in KwaZulu-Natal, South Africa. Poster presented at 21st International Aids Conference; 2016 July 18-22; Durban, South Africa.
Beksinska M, Nkosi P, Mabude Z, Smit J, Zulu B, Phungula L, Greener R, Kubeka M, Milford C, Lazarus N, Jali Z, Mantell JE. Twenty years of the female condom programme in South Africa: past, present and future. South African Health Review, 2017. Chapter 14. In: Padarath A, Barron P, editors. South African Health Review 2017. Durban: Health Systems Trust; 2017.
The purpose of this study was to evaluate the functional performance of the Wondaleaf female condom. Primary endpoints will be total clinical failure and total device failure. Secondary objectives were to assess acceptability and safety data (as determined by the number of adverse events) on each female condom type.
This study aimed to enroll up to 55 healthy women protected from pregnancy by an effective method of contraception. Recruitment was from the Commercial City MatCH Research Unit site in Durban, South Africa. Participants were randomized to condom use order. Each woman was asked to use five Wondaleaf female condoms and five FC2 female condoms. Function, safety, and acceptability was assessed at two follow-up visits approximately one month after enrollment.
After ethics approvals were received, the study began in July 2017, and closed in November 2017. MRU is finalizing the data analyses and reporting, and will draft a manuscript to submit to a peer-reviewed journal to share the study results.
This study was implemented by MRU, and funded by Twin Catalyst, Malaysia.
A pilot study evaluating the functionality of the Panty Condom
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
Mauck et.al. Critical next steps for female condom research – report from a workshop. Contraception. 2009 May;79(5):339-44.
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.