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NCT01223313 · ClinicalTrials.gov registry record · NA
A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom
A NA study, sponsored by Premier Research.
- Completed
- Registry status
- NA
- Development phase
- 511
- Enrollment target
NCT01223313 is a NA study that has completed, run by Premier Research. The registered enrollment target is 511 participants.
The verdict
NCT01223313, a NA study, has completed, sponsored by Premier Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 511 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Woman's Condom
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01223313
The ClinicalTrials.gov registry entry for NCT01223313 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Premier Research, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Woman's Condom is the first listed.
NCT01223313 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01223313 about?
NCT01223313 is a clinical study titled "A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom". 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 ...
What is the current status of trial NCT01223313?
This trial is currently completed. It is a NA study. The enrollment target is 511 participants. The study started on 2011-01. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01223313?
The interventions under investigation include: Woman's Condom (DEVICE).
Who is sponsoring clinical trial NCT01223313?
This trial is sponsored by Premier Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
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