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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
586
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
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)
Time frame: At or by the Week 16 visit
Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)
Time frame: At or by the Week 16 visit
Recurrence of Patient-reported BV Symptoms
Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)
Time frame: At or by the Week 16 visit
Recurrence of Individual Amsel Criteria
Number of participants with positive individual Amsel criterion \- Clue cells representing at least 20% of total epithelial cells
Time frame: At or by the Week 16 visit
Recurrence of BV as Determined by Presence of a Nugent Score of 7-10
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.
Time frame: 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
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)
Time frame: At or by the Week 24 visit
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University of Alabama
Birmingham, Alabama, United States
Montgomery Women's Health Associates
Montgomery, Alabama, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Precision Research Institute
San Diego, California, United States
Women's Health Care
San Diego, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Downtown Women's Health Care
Denver, Colorado, United States
The Community Research South Florida
Hialeah, Florida, United States
Florida Medical Center and Research Inc.
Miami, Florida, United States
Research Institute of South Florida
Miami, Florida, United States
...and 35 more locations
Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.
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.
Time frame: At or by the Week 16 visit
Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score
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.
Time frame: Baseline to Week 16
Adverse Events (AEs)
Number of participants with genitourinary AEs considered potentially related to study treatment
Time frame: From Baseline to end of Week 28