- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01201057
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
June 3, 2019 updated by: Starpharma Pty Ltd
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
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85032
- Precision Trials
-
-
Colorado
-
Denver, Colorado, United States, 80218
- Downtown Women's Health Care
-
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Nevada
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Las Vegas, Nevada, United States, 89104
- Clinical Research Center of Nevada
-
-
Texas
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Irving, Texas, United States, 75061
- Bexar Clinical Trials, LLC
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Virginia
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Virginia Beach, Virginia, United States, 23456
- Tidewater Clinical Research Inc
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 0.5% SPL7013 Gel
|
Vaginal gel
|
EXPERIMENTAL: 1.0% SPL7013 Gel
|
Vaginal gel
|
EXPERIMENTAL: 3.0% SPL7013 Gel
|
Vaginal gel
|
PLACEBO_COMPARATOR: Placebo Gel
|
Vaginal gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Women With Clinical Cure as a Measure of Efficacy
Time Frame: Day 21-30
|
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
|
Day 21-30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Women With Clinical Cure as a Measure of Efficacy
Time Frame: Day 9-12
|
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
|
Day 9-12
|
Number of Women With Nugent Cure as a Measure of Efficacy
Time Frame: Day 9-30
|
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.
|
Day 9-30
|
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
Time Frame: Day 9-30
|
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.
|
Day 9-30
|
Incidence of Genital Adverse Events Potentially Related to Treatment
Time Frame: For the duration of the study (up to Visit Day 21-30)
|
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.
|
For the duration of the study (up to Visit Day 21-30)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne Macek, MD, contracted to Starpharma Pty Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
May 1, 2011
Study Registration Dates
First Submitted
August 30, 2010
First Submitted That Met QC Criteria
September 12, 2010
First Posted (ESTIMATE)
September 14, 2010
Study Record Updates
Last Update Posted (ACTUAL)
June 6, 2019
Last Update Submitted That Met QC Criteria
June 3, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPL7013-013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bacterial Vaginosis
-
Alfasigma S.p.A.ParexelTerminatedBACTERIAL VAGINOSISUnited States
-
CDA Research Group, Inc.TerminatedBacterial Vaginosis (BV)United States
-
University of Alabama at BirminghamWayne State UniversityCompletedRecurrent Bacterial VaginosisUnited States
-
Zagazig UniversityUnknownBacterial Vaginosis TreatmentEgypt
-
Unity Health TorontoCompleted
-
Zagazig UniversityRecruitingBacterial Vaginosis | Vaginal | MicrobiologyEgypt
-
Starpharma Pty LtdCompletedRecurrent Bacterial Vaginosis (BV)
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