Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
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
1 other identifier
interventional
586
3 countries
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedStudy Start
First participant enrolled
October 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2017
CompletedResults Posted
Study results publicly available
July 9, 2019
CompletedJuly 22, 2019
July 1, 2019
2.2 years
September 5, 2014
May 7, 2019
July 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)
At or by the Week 16 visit
Secondary Outcomes (8)
Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
At or by the Week 16 visit
Recurrence of Patient-reported BV Symptoms
At or by the Week 16 visit
Recurrence of Individual Amsel Criteria
At or by the Week 16 visit
Recurrence of BV as Determined by Presence of a Nugent Score of 7-10
At or by the Week 16 visit
Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
At or by the Week 24 visit
- +3 more secondary outcomes
Study Arms (2)
1% SPL7013 Gel
EXPERIMENTALInserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Placebo Gel
PLACEBO COMPARATORInserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Interventions
One tablet taken orally twice daily for seven consecutive days
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Eligibility Criteria
You may qualify if:
- Current active episode of BV (diagnosis defined as: At least 3 of the 4 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)
- History of recurrent BV (at least 3 episodes in previous year including current episode)
- Using an effective method of contraception
You may not qualify if:
- Test positive for a sexually transmitted infection
- Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment
- Abnormal pelvic exam, including presence of other vaginal or urinary tract infections
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
University of Alabama
Birmingham, Alabama, 35233, United States
Montgomery Women's Health Associates
Montgomery, Alabama, 36117, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Precision Research Institute
San Diego, California, 92114, United States
Women's Health Care
San Diego, California, 92123, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80907, United States
Downtown Women's Health Care
Denver, Colorado, 80209, United States
The Community Research South Florida
Hialeah, Florida, 33016, United States
Florida Medical Center and Research Inc.
Miami, Florida, 33142, United States
Research Institute of South Florida
Miami, Florida, 33173, United States
Community Medical Research
Miami Beach, Florida, 33141, United States
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, 30041, United States
Urban Family Practice Associates
Marietta, Georgia, 30067, United States
Heartland Research Associates, LLC
Newton, Kansas, 67114, United States
Women's Healthcare Specialists
Paw Paw, Michigan, 49079, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510, United States
Alegent Creighton Health
Omaha, Nebraska, 68154, United States
Affiliated Clinical Research
Las Vegas, Nevada, 89105, United States
Lawrence OB-GYN Associates
Lawrenceville, New Jersey, 08648, United States
PMG Research of Cary, LLC
Cary, North Carolina, 27518, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
Radiant Research
Akron, Ohio, 44311, United States
Radiant Research
Columbus, Ohio, 43212, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Clinical Research Advantage
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 49425, United States
Chattanooga Medical Research
Chattanooga, Tennessee, 37404, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Women's Physician Group
Memphis, Tennessee, 38104, United States
Practice Research Organization
Dallas, Texas, 75230, United States
Radiant Research
San Antonio, Texas, 78229, United States
Jordan River Family Medicine
South Jordan, Utah, 84088, United States
Clinical Trials of Virginia
Richmond, Virginia, 23225, United States
Women's Clinical Research Center
Seattle, Washington, 98105, United States
Medicine Professional Corporation
Kitchener, Ontario, N2G1H6, Canada
SKDS Research Inc
Newmarket, Ontario, L3Y5G8, Canada
Healthy Image Centre
Windsor, Ontario, N955C6, Canada
DIEX Recherche Montreal Inc
Montreal, Quebec, H4N3C5, Canada
DIEX Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1H1Z1, Canada
Torre Auxillo Mutuo
Hato Rey, 00917, Puerto Rico
Latin Clinical Trial Center
San Juan, 00918, Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Jeremy Paull
- Organization
- Starpharma
Study Officials
- STUDY CHAIR
Jeremy Paull, PhD.
Starpharma Pty Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2014
First Posted
September 12, 2014
Study Start
October 13, 2014
Primary Completion
December 9, 2016
Study Completion
February 22, 2017
Last Updated
July 22, 2019
Results First Posted
July 9, 2019
Record last verified: 2019-07