Prostate Specific Antigen (PSA) and Acute Failure Modes Study of the PATH Woman's Condom and FC2 Female Condom
Public ClinicalTrials.gov record NCT01178840. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01178840
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 505 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2010
- Primary completion
- May 31, 2011
- Completion
- May 31, 2011
- Last update posted
- Dec 11, 2013
2010 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Family Health Council | Los Angeles | California | 90010 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01178840, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 11, 2013 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01178840 live on ClinicalTrials.gov.