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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: Completed Phase 3 study, sponsored by Evofem.
NCT01306331 is a Phase 3 study that has completed, run by Evofem. The registered enrollment target is 3,389 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (339% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint was the evaluation of contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the MITT population by treatment group
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 |
What the finished NCT01306331 record still lists
NCT01306331 is an interventional study that assigns participants to a tested intervention. Its 3,389 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (339% higher).
The record links to 0 conditions, and to 2 interventions - of which Conceptrol is the first listed.
NCT01306331 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01306331's enrollment target sits among peer trials
3,389 72nd of 2000 higher than 1,929 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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