Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
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
1 other identifier
interventional
132
1 country
5
Brief Summary
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2010
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
September 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
June 6, 2019
CompletedJune 6, 2019
June 1, 2019
7 months
August 30, 2010
April 29, 2019
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Day 21-30
Secondary Outcomes (4)
Number of Women With Clinical Cure as a Measure of Efficacy
Day 9-12
Number of Women With Nugent Cure as a Measure of Efficacy
Day 9-30
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
Day 9-30
Incidence of Genital Adverse Events Potentially Related to Treatment
For the duration of the study (up to Visit Day 21-30)
Study Arms (4)
0.5% SPL7013 Gel
EXPERIMENTAL1.0% SPL7013 Gel
EXPERIMENTAL3.0% SPL7013 Gel
EXPERIMENTALPlacebo Gel
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
- Otherwise healthy
You may not qualify if:
- No active STIs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Precision Trials
Phoenix, Arizona, 85032, United States
Downtown Women's Health Care
Denver, Colorado, 80218, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Bexar Clinical Trials, LLC
Irving, Texas, 75061, United States
Tidewater Clinical Research Inc
Virginia Beach, Virginia, 23456, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Jeremy Paull
- Organization
- Starpharma
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Macek, MD
contracted to Starpharma Pty Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2010
First Posted
September 14, 2010
Study Start
August 1, 2010
Primary Completion
March 1, 2011
Study Completion
May 1, 2011
Last Updated
June 6, 2019
Results First Posted
June 6, 2019
Record last verified: 2019-06