Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
Public ClinicalTrials.gov record NCT01306331. 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.
Official title
A Multicenter, Open-Label, Randomized Study of the Contraceptive Efficacy and Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01306331
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,389 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 35 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
- Apr 2011 (Type not available)
- Primary completion
- Jun 2014 (Actual)
- Completion
- Jun 2014 (Actual)
- Last update posted
- Jul 12, 2022
2011 – 2014
United States locations
- U.S. sites
- 41
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | — |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72205 | — |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| California Family Health Council, Inc. | Berkeley | California | 94710 | — |
| California Family and Health Council, Inc., LA | Los Angeles | California | 90010 | — |
| California Family Health Council | Los Angeles | California | 90010 | — |
| Women's Health Care | San Diego | California | 92123 | — |
| Downtown Women's Healthcare | Denver | Colorado | 61820 | — |
| Planned Parenthood of the Rocky Mountains | Denver | Colorado | 80302 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06095 | — |
| Meridien Research | Bradenton | Florida | 34208 | — |
| Avail Clinical Reseach | DeLand | Florida | 32720 | — |
| Altus Research | Lake Worth | Florida | 33461 | — |
| Miami Research Associates | Miami | Florida | 33143 | — |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Comprehensive Clinical Trials | West Palm Beach | Florida | 33409 | — |
| Soapstone Center for Clinical Research | Decatur | Georgia | 30034 | — |
| Rosemark WomenCare Specialist | Idaho Falls | Idaho | 83404 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| Johns Hopkins Community Physicians | Baltimore | Maryland | 21211 | — |
| Impact Clinical Trials | Las Vegas | Nevada | 89106 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| NYU Medical Center Family Planning | New York | New York | 10016 | — |
| Columbia University Medical Center, Division of Family Planning | New York | New York | 10032 | — |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Planned Parenthood of Northeast Ohio | Cleveland | Ohio | 44302 | — |
| Oregon Health Sciences University | Portland | Oregon | 97239 | — |
| University of Pennsylvania Medical Center, Reproductive Research Unit | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia Clinical Research | Philadelphia | Pennsylvania | 19114 | — |
| Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | — |
| Practice Research Organization | Dallas | Texas | 75230 | — |
| UT Southwestern Medical Center - Dept. of OB/GYN | Dallas | Texas | 75390 | — |
| TMC Life Research, Inc | Houston | Texas | 77054 | — |
| MacArthur OB/GYN | Irving | Texas | 75062 | — |
| Jean Brown Research | Salt Lake City | Utah | 84124 | — |
| Women's Clinical Research Center | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01306331, 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 Jul 12, 2022 · 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 NCT01306331 live on ClinicalTrials.gov.