Clinical trial NCT02237950: Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Lead sponsor: Starpharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 586
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
timeFrame: At or by the Week 16 visit
Secondary outcomes:
measure: Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
timeFrame: At or by the Week 16 visit
measure: Recurrence of Patient-reported BV Symptoms
timeFrame: At or by the Week 16 visit
measure: Recurrence of Individual Amsel Criteria
timeFrame: At or by the Week 16 visit
measure: Recurrence of BV as Determined by Presence of a Nugent Score of 7-10
timeFrame: At or by the Week 16 visit
measure: Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
timeFrame: At or by the Week 24 visit
measure: Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.
timeFrame: At or by the Week 16 visit
measure: Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score
timeFrame: Baseline to Week 16
measure: Adverse Events (AEs)
timeFrame: From Baseline to end of Week 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Women's Health Associates
state: Alabama
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: San Diego
country: United States
facility: Women's Health Care
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Hialeah
country: United States
facility: The Community Research South Florida
state: Florida
city: Miami Beach
country: United States
facility: Community Medical Research
state: Florida
city: Miami
country: United States
facility: Florida Medical Center and Research Inc.
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute
state: Georgia
city: Marietta
country: United States
facility: Urban Family Practice Associates
state: Georgia
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Paw Paw
country: United States
facility: Women's Healthcare Specialists
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Omaha
country: United States
facility: Alegent Creighton Health
state: Nebraska
city: Las Vegas
country: United States
facility: Affiliated Clinical Research
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence OB-GYN Associates
state: New Jersey
city: Cary
country: United States
facility: PMG Research of Cary, LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: Anderson
country: United States
facility: Clinical Research Advantage
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Memphis
country: United States
facility: Women's Physician Group
state: Tennessee
city: Dallas
country: United States
facility: Practice Research Organization
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: South Jordan
country: United States
facility: Jordan River Family Medicine
state: Utah
city: Richmond
country: United States
facility: Clinical Trials of Virginia
state: Virginia
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
city: Kitchener
country: Canada
facility: Medicine Professional Corporation
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc
state: Ontario
city: Windsor
country: Canada
facility: Healthy Image Centre
state: Ontario
city: Montreal
country: Canada
facility: DIEX Recherche Montreal Inc
state: Quebec
city: Sherbrooke
country: Canada
facility: DIEX Recherche Sherbrooke Inc.
state: Quebec
city: Hato Rey
country: Puerto Rico
facility: Torre Auxillo Mutuo
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: Starpharma Pty Ltd
name: Jeremy Paull, PhD.
role: STUDY_CHAIR
References: