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NCT01178840 · ClinicalTrials.gov registry record · NA
Prostate Specific Antigen (PSA) and Acute Failure Modes Study of the PATH Woman's Condom and FC2 Female Condom
A NA study, sponsored by CONRAD.
- Completed
- Registry status
- NA
- Development phase
- 505
- Enrollment target
NCT01178840: Completed NA study, sponsored by CONRAD.
NCT01178840 is a NA study that has completed, run by CONRAD. The registered enrollment target is 505 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01178840, a NA study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- NA
- Development phase
- 505 participants
- Enrollment target
Study Summary
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 t
Interventions
- DEVICE WC then FC2
- DEVICE FC2 then WC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 505 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-06 |
| Phase | NA |
What the finished NCT01178840 record still lists
NCT01178840 is an interventional study that assigns participants to a tested intervention. The registered 505 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which WC then FC2 is the first listed.
NCT01178840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01178840 about?
NCT01178840 is a clinical study titled "Prostate Specific Antigen (PSA) and Acute Failure Modes Study of the PATH Woman's Condom and FC2 Female Condom". 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, vagin...
What is the current status of trial NCT01178840?
This trial is currently completed. It is a NA study. The enrollment target is 505 participants. The study started on 2010-07. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01178840?
The interventions under investigation include: WC then FC2 (DEVICE), FC2 then WC (DEVICE).
Who is sponsoring clinical trial NCT01178840?
This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01178840's enrollment target sits among peer trials
505 193rd of 2000 higher than 1,808 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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