Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237950
• Other study ID #: SPL7013-017
• Status: Completed
• Phase: Phase 3
• Start date: October 13, 2014
• Est. completion date: February 22, 2017

Study information

• Verified date: July 2019
• Source: Starpharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 586
• Est. completion date: February 22, 2017
• Est. primary completion date: December 9, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Recurrence
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
• 1% SPL7013 Gel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
• Placebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Locations

Country	Name	City	State
Canada	Medicine Professional Corporation	Kitchener	Ontario
Canada	DIEX Recherche Montreal Inc	Montreal	Quebec
Canada	SKDS Research Inc	Newmarket	Ontario
Canada	DIEX Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Healthy Image Centre	Windsor	Ontario
Puerto Rico	Torre Auxillo Mutuo	Hato Rey
Puerto Rico	Latin Clinical Trial Center	San Juan
Puerto Rico	University of Puerto Rico	San Juan
United States	Radiant Research	Akron	Ohio
United States	Atlanta Medical Research Institute	Alpharetta	Georgia
United States	Clinical Research Advantage	Anderson	South Carolina
United States	University of Alabama	Birmingham	Alabama
United States	PMG Research of Cary, LLC	Cary	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Chattanooga Medical Research	Chattanooga	Tennessee
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Radiant Research	Columbus	Ohio
United States	Practice Research Organization	Dallas	Texas
United States	Downtown Women's Health Care	Denver	Colorado
United States	The Community Research South Florida	Hialeah	Florida
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Affiliated Clinical Research	Las Vegas	Nevada
United States	Lawrence OB-GYN Associates	Lawrenceville	New Jersey
United States	Women's Clinic of Lincoln, PC	Lincoln	Nebraska
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Urban Family Practice Associates	Marietta	Georgia
United States	Women's Physician Group	Memphis	Tennessee
United States	Florida Medical Center and Research Inc.	Miami	Florida
United States	Research Institute of South Florida	Miami	Florida
United States	Community Medical Research	Miami Beach	Florida
United States	Montgomery Women's Health Associates	Montgomery	Alabama
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Alegent Creighton Health	Omaha	Nebraska
United States	Women's Healthcare Specialists	Paw Paw	Michigan
United States	Clinical Research of Philadelphia	Philadelphia	Pennsylvania
United States	Clinical Trials of Virginia	Richmond	Virginia
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Radiant Research	San Antonio	Texas
United States	Precision Research Institute	San Diego	California
United States	Women's Health Care	San Diego	California
United States	Women's Clinical Research Center	Seattle	Washington
United States	Jordan River Family Medicine	South Jordan	Utah
United States	Comprehensive Clinical Trials	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Starpharma Pty Ltd

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events (AEs)	Number of participants with genitourinary AEs considered potentially related to study treatment	From Baseline to end of Week 28