Back to resultsDose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
Primary Purpose
Bacterial Vaginosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.5% SPL7013 Gel
1.0% SPL7013 Gel
3.0% SPL7013 Gel
Placebo Gel
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis focused on measuring SPL7013, VivaGel, bacterial vaginosis, BV
Eligibility Criteria
Inclusion Criteria:
- Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
- Otherwise healthy
Exclusion Criteria:
- No active STIs
Sites / Locations
- Precision Trials
- Downtown Women's Health Care
- Clinical Research Center of Nevada
- Bexar Clinical Trials, LLC
- Tidewater Clinical Research Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
0.5% SPL7013 Gel
1.0% SPL7013 Gel
3.0% SPL7013 Gel
Placebo Gel
Arm Description
Outcomes
Primary Outcome Measures
Number of Women With Clinical Cure as a Measure of Efficacy
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Secondary Outcome Measures
Number of Women With Clinical Cure as a Measure of Efficacy
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Number of Women With Nugent Cure as a Measure of Efficacy
Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.
Incidence of Genital Adverse Events Potentially Related to Treatment
Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01201057
Brief Title
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
Official Title
A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Starpharma Pty Ltd
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
SPL7013, VivaGel, bacterial vaginosis, BV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.5% SPL7013 Gel
Arm Type
Experimental
Arm Title
1.0% SPL7013 Gel
Arm Type
Experimental
Arm Title
3.0% SPL7013 Gel
Arm Type
Experimental
Arm Title
Placebo Gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
0.5% SPL7013 Gel
Intervention Description
Vaginal gel
Intervention Type
Drug
Intervention Name(s)
1.0% SPL7013 Gel
Intervention Description
Vaginal gel
Intervention Type
Drug
Intervention Name(s)
3.0% SPL7013 Gel
Intervention Description
Vaginal gel
Intervention Type
Other
Intervention Name(s)
Placebo Gel
Intervention Description
Vaginal gel
Primary Outcome Measure Information:
Title
Number of Women With Clinical Cure as a Measure of Efficacy
Description
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Time Frame
Day 21-30
Secondary Outcome Measure Information:
Title
Number of Women With Clinical Cure as a Measure of Efficacy
Description
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Time Frame
Day 9-12
Title
Number of Women With Nugent Cure as a Measure of Efficacy
Description
Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.
Time Frame
Day 9-30
Title
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
Description
Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.
Time Frame
Day 9-30
Title
Incidence of Genital Adverse Events Potentially Related to Treatment
Description
Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.
Time Frame
For the duration of the study (up to Visit Day 21-30)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
Otherwise healthy
Exclusion Criteria:
No active STIs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Macek, MD
Organizational Affiliation
contracted to Starpharma Pty Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Precision Trials
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Downtown Women's Health Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Bexar Clinical Trials, LLC
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Tidewater Clinical Research Inc
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
12. IPD Sharing Statement
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Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
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