Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
- Conditions
- Bacterial Vaginosis
- Interventions
- Registration Number
- NCT02237950
- Lead Sponsor
- Starpharma Pty Ltd
- 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.
- Detailed Description
Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.
The primary endpoint will be determined at the conclusion of this 16 week treatment phase.
Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.
Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.
Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 586
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1% SPL7013 Gel 1% SPL7013 Gel Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Placebo Gel Placebo gel Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 1% SPL7013 Gel Metronidazole oral tablets 500mg Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Placebo Gel Metronidazole oral tablets 500mg Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
- Primary Outcome Measures
Name Time Method 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 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)
- Secondary Outcome Measures
Name Time Method Recurrence of Individual Amsel Criteria At or by the Week 16 visit Number of participants with positive individual Amsel criterion
- Clue cells representing at least 20% of total epithelial cellsTime 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 Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)
Recurrence of Patient-reported BV Symptoms At or by the Week 16 visit Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)
Recurrence of BV as Determined by Presence of a Nugent Score of 7-10 At or by the Week 16 visit Number of participants with a recurrence of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.
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 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)
Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10. At or by the Week 16 visit Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.
Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score Baseline to Week 16 Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.
Adverse Events (AEs) From Baseline to end of Week 28 Number of participants with genitourinary AEs considered potentially related to study treatment
Trial Locations
- Locations (43)
Florida Medical Center and Research Inc.
🇺🇸Miami, Florida, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Women's Clinic of Lincoln, PC
🇺🇸Lincoln, Nebraska, United States
Women's Healthcare Specialists
🇺🇸Paw Paw, Michigan, United States
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Montgomery Women's Health Associates
🇺🇸Montgomery, Alabama, United States
The Community Research South Florida
🇺🇸Hialeah, Florida, United States
SKDS Research Inc
🇨🇦Newmarket, Ontario, Canada
PMG Research of Cary, LLC
🇺🇸Cary, North Carolina, United States
DIEX Recherche Montreal Inc
🇨🇦Montreal, Quebec, Canada
Comprehensive Clinical Trials
🇺🇸West Palm Beach, Florida, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Heartland Research Associates, LLC
🇺🇸Newton, Kansas, United States
Precision Research Institute
🇺🇸San Diego, California, United States
Women's Health Care
🇺🇸San Diego, California, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Research Institute of South Florida
🇺🇸Miami, Florida, United States
Community Medical Research
🇺🇸Miami Beach, Florida, United States
Lawrence OB-GYN Associates
🇺🇸Lawrenceville, New Jersey, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Practice Research Organization
🇺🇸Dallas, Texas, United States
Clinical Research of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research Advantage
🇺🇸Anderson, South Carolina, United States
Women's Clinical Research Center
🇺🇸Seattle, Washington, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
Healthy Image Centre
🇨🇦Windsor, Ontario, Canada
Urban Family Practice Associates
🇺🇸Marietta, Georgia, United States
Atlanta Medical Research Institute
🇺🇸Alpharetta, Georgia, United States
Chattanooga Medical Research
🇺🇸Chattanooga, Tennessee, United States
Affiliated Clinical Research
🇺🇸Las Vegas, Nevada, United States
Women's Physician Group
🇺🇸Memphis, Tennessee, United States
Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
Medicine Professional Corporation
🇨🇦Kitchener, Ontario, Canada
DIEX Recherche Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Torre Auxillo Mutuo
🇵🇷Hato Rey, Puerto Rico
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Alegent Creighton Health
🇺🇸Omaha, Nebraska, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Clinical Trials of Virginia
🇺🇸Richmond, Virginia, United States
Radiant Research
🇺🇸San Antonio, Texas, United States