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NCT01306331 · ClinicalTrials.gov registry record · Phase 3
Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
A Phase 3 study, sponsored by Evofem.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,389
- Enrollment target
NCT01306331 is a Phase 3 study that has completed, run by Evofem. The registered enrollment target is 3,389 participants.
The verdict
NCT01306331, a Phase 3 study, has completed, sponsored by Evofem.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,389 participants
- Enrollment target
Study Summary
This is a research study of a new experimental vaginal gel that helps in vaginal pH regulation and results in immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen. This vaginal gel is called Phexxi™ (previously known as Amphora) and was compared to a commercially available spermicide called Conceptrol®, which contains nonoxynol 9; commonly abbreviated as N-9. Conceptrol® can help prevent pregnancy. This study objective was to determine if this product prevents pregnancy when inserted into the vagina before intercourse.
Interventions
- DRUG Conceptrol
- DRUG Amphora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,389 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01306331
The ClinicalTrials.gov registry entry for NCT01306331 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,389 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Evofem, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Conceptrol is the first listed.
NCT01306331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01306331 about?
NCT01306331 is a clinical study titled "Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel". This is a research study of a new experimental vaginal gel that helps in vaginal pH regulation and results in immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen. This vaginal gel is called Phexxi™ (previously known as Amphora) and was compared to ...
What is the current status of trial NCT01306331?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,389 participants. The study started on 2011-04. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01306331?
The interventions under investigation include: Conceptrol (DRUG), Amphora (DRUG).
Who is sponsoring clinical trial NCT01306331?
This trial is sponsored by Evofem, which has 6 total clinical trials registered on ClinicalTrials.gov.
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