Prostate Specific Antigen (PSA) and Acute Failure Modes Study of the PATH Woman's Condom and FC2 Female Condom
| Status: | Archived |
|---|---|
| Conditions: | Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2010 |
| End Date: | August 2011 |
A Randomized Cross-Over Study of Vaginal Semen Exposure and Clinical Failure Comparing the PATH Woman's Condom and the FC2 Female Condom
This is a comparative, open-label two-period crossover study of up to 425 couples comparing
the PATH Woman's Condom to the FC2 female condom. California Family Health Council will
enroll up to 425 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.
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 425 couples
comparing the PATH Woman's Condom to the FC2 female condom. We will enroll up to 425 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).
Secondary objectives:
- 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 425 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)
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