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

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 Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: Metronidazole oral tablets 500mg; Drug: 1% SPL7013 Gel; Drug: Placebo gel

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.

• Study Type: Interventional
• Enrollment (Actual): 586
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kitchener, Ontario, Canada, N2G1H6
      • Medicine Professional Corporation
    • Newmarket, Ontario, Canada, L3Y5G8
      • Skds Research Inc
    • Windsor, Ontario, Canada, N955C6
      • Healthy Image Centre
  • Quebec
    • Montreal, Quebec, Canada, H4N3C5
      • DIEX Recherche Montreal Inc
    • Sherbrooke, Quebec, Canada, J1H1Z1
      • Diex Recherche Sherbrooke Inc.
• Puerto Rico
  • Hato Rey, Puerto Rico, 00917
    • Torre Auxillo Mutuo
  • San Juan, Puerto Rico
    • University of Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Latin Clinical Trial Center
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama
    • Montgomery, Alabama, United States, 36117
      • Montgomery Women's Health Associates
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
  • California
    • San Diego, California, United States, 92114
      • Precision Research Institute
    • San Diego, California, United States, 92123
      • Women's Health Care
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Lynn Institute of the Rockies
    • Denver, Colorado, United States, 80209
      • Downtown Women's Health Care
  • Florida
    • Hialeah, Florida, United States, 33016
      • The Community Research South Florida
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida
    • Miami, Florida, United States, 33142
      • Florida Medical Center and Research Inc.
    • Miami Beach, Florida, United States, 33141
      • COMMUNITY Medical Research
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials
  • Georgia
    • Alpharetta, Georgia, United States, 30041
      • Atlanta Medical Research Institute
    • Marietta, Georgia, United States, 30067
      • Urban Family Practice Associates
  • Kansas
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
  • Michigan
    • Paw Paw, Michigan, United States, 49079
      • Women's Healthcare Specialists
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, PC
    • Omaha, Nebraska, United States, 68154
      • Alegent Creighton Health
  • Nevada
    • Las Vegas, Nevada, United States, 89105
      • Affiliated Clinical Research
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence OB-GYN Associates
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Cary, LLC
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research
    • Columbus, Ohio, United States, 43212
      • Radiant Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Lynn Institute of Norman
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Clinical Research Advantage
    • Charleston, South Carolina, United States, 49425
      • Medical University of South Carolina
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group
    • Memphis, Tennessee, United States, 38104
      • Women's Physician Group
  • Texas
    • Dallas, Texas, United States, 75230
      • Practice Research Organization
    • San Antonio, Texas, United States, 78229
      • Radiant Research
  • Utah
    • South Jordan, Utah, United States, 84088
      • Jordan River Family Medicine
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Clinical Trials of Virginia
  • Washington
    • Seattle, Washington, United States, 98105
      • Women's Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1% SPL7013 Gel; Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks	Drug: Metronidazole oral tablets 500mg; One tablet taken orally twice daily for seven consecutive days; Drug: 1% SPL7013 Gel; 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.; Other Names: VivaGel; astodimer sodium
PLACEBO_COMPARATOR: Placebo Gel; Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks	Drug: Metronidazole oral tablets 500mg; One tablet taken orally twice daily for seven consecutive days; Drug: Placebo gel; 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	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.	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)	At or by the Week 24 visit
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.	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.	Baseline to Week 16
Adverse Events (AEs)	Number of participants with genitourinary AEs considered potentially related to study treatment	From Baseline to end of Week 28

Collaborators and Investigators

• Sponsor: Starpharma Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2014
• Primary Completion (ACTUAL): December 9, 2016
• Study Completion (ACTUAL): February 22, 2017

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 11, 2014
• First Posted (ESTIMATE): September 12, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Recurrence; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: SPL7013-017