Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by CONRAD. The registered enrollment target is 505 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01178840
The ClinicalTrials.gov registry entry for NCT01178840 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 505 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CONRAD, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which WC then FC2 is the first listed.
NCT01178840 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.