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

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Metronidazole oral tablets 500mg
1% SPL7013 Gel
Placebo gel
Sponsored by
Starpharma Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Vaginosis

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Montgomery Women's Health Associates
  • Lynn Institute of the Ozarks
  • Precision Research Institute
  • Women's Health Care
  • Lynn Institute of the Rockies
  • Downtown Women's Health Care
  • The Community Research South Florida
  • Community Medical Research
  • Florida Medical Center and Research Inc.
  • Research Institute of South Florida
  • Comprehensive Clinical Trials
  • Atlanta Medical Research Institute
  • Urban Family Practice Associates
  • Heartland Research Associates, LLC
  • Women's Healthcare Specialists
  • Women's Clinic of Lincoln, PC
  • Alegent Creighton Health
  • Affiliated Clinical Research
  • Lawrence OB-GYN Associates
  • PMG Research of Cary, LLC
  • PMG Research of Salisbury
  • Radiant Research
  • Radiant Research
  • Lynn Institute of Norman
  • Lynn Health Science Institute
  • Clinical Research of Philadelphia
  • Clinical Research Advantage
  • Medical University of South Carolina
  • Chattanooga Medical Research
  • Volunteer Research Group
  • Women's Physician Group
  • Practice Research Organization
  • Radiant Research
  • Jordan River Family Medicine
  • Clinical Trials of Virginia
  • Women's Clinical Research Center
  • Medicine Professional Corporation
  • SKDS Research Inc
  • Healthy Image Centre
  • DIEX Recherche Montreal Inc
  • DIEX Recherche Sherbrooke Inc.
  • Torre Auxillo Mutuo
  • Latin Clinical Trial Center
  • University of Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1% SPL7013 Gel

Placebo Gel

Arm Description

Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks

Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Recurrence of Patient-reported BV Symptoms
Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)
Recurrence of Individual Amsel Criteria
Number of participants with positive individual Amsel criterion - Clue cells representing at least 20% of total epithelial cells
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.
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)
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.
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.
Adverse Events (AEs)
Number of participants with genitourinary AEs considered potentially related to study treatment

Full Information

First Posted
September 5, 2014
Last Updated
July 8, 2019
Sponsor
Starpharma Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02237950
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 13, 2014 (Actual)
Primary Completion Date
December 9, 2016 (Actual)
Study Completion Date
February 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Starpharma Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
586 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1% SPL7013 Gel
Arm Type
Experimental
Arm Description
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Arm Title
Placebo Gel
Arm Type
Placebo Comparator
Arm Description
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Metronidazole oral tablets 500mg
Intervention Description
One tablet taken orally twice daily for seven consecutive days
Intervention Type
Drug
Intervention Name(s)
1% SPL7013 Gel
Other Intervention Name(s)
VivaGel, astodimer sodium
Intervention Description
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo gel
Intervention Description
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Primary Outcome Measure Information:
Title
Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
Description
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
Secondary Outcome Measure Information:
Title
Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
Description
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
Title
Recurrence of Patient-reported BV Symptoms
Description
Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)
Time Frame
At or by the Week 16 visit
Title
Recurrence of Individual Amsel Criteria
Description
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
Title
Recurrence of BV as Determined by Presence of a Nugent Score of 7-10
Description
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
Title
Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
Description
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
Title
Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.
Description
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
Title
Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score
Description
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
Title
Adverse Events (AEs)
Description
Number of participants with genitourinary AEs considered potentially related to study treatment
Time Frame
From Baseline to end of Week 28

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Paull, PhD.
Organizational Affiliation
Starpharma Pty Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Montgomery Women's Health Associates
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Women's Health Care
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Downtown Women's Health Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
The Community Research South Florida
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Community Medical Research
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33141
Country
United States
Facility Name
Florida Medical Center and Research Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Research Institute of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Comprehensive Clinical Trials
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Medical Research Institute
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Facility Name
Urban Family Practice Associates
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Women's Healthcare Specialists
City
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
Country
United States
Facility Name
Women's Clinic of Lincoln, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Alegent Creighton Health
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68154
Country
United States
Facility Name
Affiliated Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89105
Country
United States
Facility Name
Lawrence OB-GYN Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
PMG Research of Cary, LLC
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Radiant Research
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Clinical Research of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Clinical Research Advantage
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
49425
Country
United States
Facility Name
Chattanooga Medical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Women's Physician Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Practice Research Organization
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Radiant Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Clinical Trials of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Women's Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Medicine Professional Corporation
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G1H6
Country
Canada
Facility Name
SKDS Research Inc
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y5G8
Country
Canada
Facility Name
Healthy Image Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N955C6
Country
Canada
Facility Name
DIEX Recherche Montreal Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N3C5
Country
Canada
Facility Name
DIEX Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H1Z1
Country
Canada
Facility Name
Torre Auxillo Mutuo
City
Hato Rey
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
University of Puerto Rico
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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