Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
Public ClinicalTrials.gov record NCT02237950. 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 Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.
Study identification
- NCT ID
- NCT02237950
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 586 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 13, 2014 (Actual)
- Primary completion
- Dec 9, 2016 (Actual)
- Completion
- Feb 22, 2017 (Actual)
- Last update posted
- Jul 22, 2019
2014 – 2017
United States locations
- U.S. sites
- 37
- U.S. states
- 21
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | — |
| Montgomery Women's Health Associates | Montgomery | Alabama | 36117 | — |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72205 | — |
| Precision Research Institute | San Diego | California | 92114 | — |
| Women's Health Care | San Diego | California | 92123 | — |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80907 | — |
| Downtown Women's Health Care | Denver | Colorado | 80209 | — |
| The Community Research South Florida | Hialeah | Florida | 33016 | — |
| Florida Medical Center and Research Inc. | Miami | Florida | 33142 | — |
| Research Institute of South Florida | Miami | Florida | 33173 | — |
| Community Medical Research | Miami Beach | Florida | 33141 | — |
| Comprehensive Clinical Trials | West Palm Beach | Florida | 33409 | — |
| Atlanta Medical Research Institute | Alpharetta | Georgia | 30041 | — |
| Urban Family Practice Associates | Marietta | Georgia | 30067 | — |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | — |
| Women's Healthcare Specialists | Paw Paw | Michigan | 49079 | — |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | — |
| Alegent Creighton Health | Omaha | Nebraska | 68154 | — |
| Affiliated Clinical Research | Las Vegas | Nevada | 89105 | — |
| Lawrence OB-GYN Associates | Lawrenceville | New Jersey | 08648 | — |
| PMG Research of Cary, LLC | Cary | North Carolina | 27518 | — |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | — |
| Radiant Research | Akron | Ohio | 44311 | — |
| Radiant Research | Columbus | Ohio | 43212 | — |
| Lynn Institute of Norman | Norman | Oklahoma | 73069 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Clinical Research of Philadelphia | Philadelphia | Pennsylvania | 19114 | — |
| Clinical Research Advantage | Anderson | South Carolina | 29621 | — |
| Medical University of South Carolina | Charleston | South Carolina | 49425 | — |
| Chattanooga Medical Research | Chattanooga | Tennessee | 37404 | — |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | — |
| Women's Physician Group | Memphis | Tennessee | 38104 | — |
| Practice Research Organization | Dallas | Texas | 75230 | — |
| Radiant Research | San Antonio | Texas | 78229 | — |
| Jordan River Family Medicine | South Jordan | Utah | 84088 | — |
| Clinical Trials of Virginia | Richmond | Virginia | 23225 | — |
| 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 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02237950, 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 22, 2019 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02237950 live on ClinicalTrials.gov.