A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom
Public ClinicalTrials.gov record NCT01223313. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
WHAT IS THE FEMALE CONDOM? The female condom being examined in this study is investigational (experimental) and is not yet approved by the Food and Drug Administration (FDA). The female condom is made up of a pouch that adjusts to the shape of the vagina. The female condom that will be used in this study is not lubricated, but a water-based lubricant will be provided for you to use with it. Also, the female condoms used in this study will be provided to you at no cost. WHY IS THIS STUDY BEING DONE? The purpose of this study is to find out: * How well the female condom works to prevent pregnancy * How well the female condom works to prevent transmission of sexually transmitted diseases * How safe the female condom is to use * If urinary tract infections and symptomatic vaginal infections occur while using the female condom * How well women like the female condom * How well the female condom performs. WHAT DOES THE STUDY INVOLVE? There will be approximately 10 clinics in the study with about 500 women from all over the United States participating in this study. You are being asked to participate in a research study because you are a woman between the ages of 18 and 40, are in general good health, have regular menstrual cycles, do not want to become pregnant for at least the next 7 months, and are willing to rely on the female condom as your primary method of contraception during study participation. HOW LONG DOES THE STUDY LAST? Enrollment for this study is expected to last about 12 months. You will need to come to the clinic for a screening/admission visit and then 2 or more visits. You will also be asked to complete a diary every day about your use of the female condoms. The clinical staff will help set up your planned clinical visits during the study.
Study identification
- NCT ID
- NCT01223313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 511 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 40 Years
- Sex
- Female
- 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
- Jan 2011 (Type not available)
- Primary completion
- Nov 2012 (Actual)
- Completion
- Sep 2015 (Actual)
- Last update posted
- Feb 9, 2026
2011 – 2015
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Family Health Council, Inc | Los Angeles | California | 90010 | — |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | — |
| NYU Medical Center Family Planning | New York | New York | 10016 | — |
| Columbia University | New York | New York | 10032 | — |
| University of Cininnati College of Medicine | Cincinnati | Ohio | 45267 | — |
| Oregon Health Scieces University | Portland | Oregon | 97239 | — |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| UT Southwestern Medical Center Dept. of OB/Gyn | Dallas | Texas | 75390 | — |
| Jones Institute of Reproductive Medicine | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01223313, 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 Feb 9, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01223313 live on ClinicalTrials.gov.