Prostate Specific Antigen (PSA) and Acute Failure Modes Study of the PATH Woman's Condom and FC2 Female Condom (CONRAD-108)
This is a comparative, open-label two-period crossover study of up to 505 couples comparing the PATH Woman's Condom to the FC2 female condom. California Family Health Council will enroll up to 505 couples to have 375 complete both periods. The study will provide data on functional performance, vaginal semen exposure, safety, and acceptability of the two female condoms.
Both partners will be required to come to the clinic to be consented for the study. If both members of the couple meet all eligibility requirements, they will each sign an informed consent form and will be enrolled as a couple. The couples will be randomized to one of two female condom use sequences for the two periods (WC then FC2 or FC2 then WC). For the first period of 2-4 weeks, the couple will be asked to have sex once without a condom and 4 times using the first assigned female condom. For the second period of 2-4 weeks, the couple will be asked to have sex 4 times using the second assigned female condom. In the first period, the couple will have one act of unprotected sex for which they will collect pre- and post-coital vaginal swabs. The couple will also use 4 female condoms of the assigned type. They will be asked to collect pre- and post-coital vaginal swabs and a post-coital swab from the condom interior. The couple will complete a detailed Condom Use Questionnaire together after each condom use. An Acceptability Questionnaire will be completed separately by males and females at the end of each study period. Couples may have additional acts of sex during each period as they desire but will not have sex at least 48 hours prior to each study sex act. After a follow-up visit, the procedures will be repeated with 4 of the second assigned condom type but without the collection of vaginal swabs at unprotected intercourse. Each couple will be enrolled for about 2-3 months, depending on the intervals between sex acts. Clinicians evaluating product-relatedness of AEs will be blinded to the condom type used. Male partners will be requested to attend the final visit, and, if they experience adverse events, the followup and/or unscheduled visits.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomized Cross-Over Study of Vaginal Semen Exposure and Clinical Failure Comparing the PATH Woman's Condom and the FC2 Female Condom|
- Self-reported clinical failure including clinical breakage, misdirection, slippage, and invagination [ Time Frame: 8 condom uses over up to 3 months ] [ Designated as safety issue: No ]
- Vaginal PSA levels [ Time Frame: 8 condom uses over up to 3 months ] [ Designated as safety issue: No ]For each sex act, the change in vaginal PSA will be examine. The change in PSA will be equal to the PSA value from the POST-coital swab minus the PSA value from the PRE-coital swab. We will also collect swabs from one sex act without a condom as a positive control.
- Female condom acceptability [ Time Frame: 8 condom uses over up to 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||June 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
WC then FC2
The couples will use 4 PATH Woman's Condom then 4 FC2 female condom.
Device: WC then FC2
4 uses of WC followed by 4 uses of FC2
FC2 then WC
The couples will use 4 FC2 female condom then 4 PATH Woman's Condom.
Device: FC2 then WC
4 uses of WC followed by 4 uses of FC2
Purpose: To compare the performance of a new female condom (PATH Woman's Condom) with an FDA-approved female condom (FC2), as assessed by reported clinical failure and vaginal PSA
Design: This is a comparative, open-label two-period crossover study of up to 505 couples comparing the PATH Woman's Condom to the FC2 female condom. We will enroll up to 505 couples at the California Family Health Council to have 375 complete both periods. The study will provide data on functional performance, vaginal semen exposure, safety, and acceptability of the two female condoms.
Primary objective: To compare the performance of the PATH Woman's Condom (WC) to the FC2, as assessed by self-reported total clinical failure and its components (clinical breakage, slippage, misdirection, and invagination).
- To compare the ability of the WC 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 using PSA as the gold standard for the presence of semen
- To compare acceptability of the WC and FC2
Study Population: Healthy heterosexual couples at least 18 years of age and at low risk for pregnancy or STIs.
Study Size: up to 505 couples divided between multiple recruitment locations under one center.
Study Duration: Accrual will require approximately 14 months. Each couple will be expected to complete the study in 2-3 months. Therefore, the clinical portion of the study should be completed within approximately 17 months. Data preparation, analysis, and report writing are expected to require up to 7 months after completion of the clinical portion.
Treatment Regimen: The couples will be randomized to one of two condom use sequences (WC then FC2 or FC2 then WC). Four condoms of each type will be used by couples over two 2-4 week periods. For first period, one set of pre- and post-coital vaginal swabs will be collected around unprotected intercourse. For each coital act where a condom is used in the period, pre and post-coital vaginal swabs and a post-coital condom swab will be collected. A Condom Use Questionnaire will be completed after each condom use. An Acceptability Questionnaire will be completed at the end of each period. After a follow-up visit, these procedures will be repeated with the second 4 condoms, without collection of vaginal swabs at unprotected intercourse.
Study Center: California Family Health Council
Funding Source: United States Agency for International Development (USAID) & National Institute for Child Health and Development (NICHD)
|United States, California|
|California Family Health Council|
|Los Angeles, California, United States, 90010|
|Study Director:||Jill L Schwartz, MD||CONRAD|