- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01437722
Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
October 27, 2013 updated by: Starpharma Pty Ltd
A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
205
Phase
- Phase 2
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 history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
- Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
- Otherwise healthy
Exclusion Criteria:
- No active STIs and/or current UTI
- Previous exposure to SPL7013 Gel
- A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1% SPL7013 Gel
|
vaginal gel
|
EXPERIMENTAL: 3% 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 who have experienced a recurrent episode of BV as a measure of efficacy
Time Frame: Day 112 +/- 5
|
Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria
|
Day 112 +/- 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jeremy Paull, PhD, 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, 2011
Primary Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
September 20, 2011
First Submitted That Met QC Criteria
September 20, 2011
First Posted (ESTIMATE)
September 21, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 20, 2013
Last Update Submitted That Met QC Criteria
October 27, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPL7013-014
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 Recurrent Bacterial Vaginosis (BV)
-
CDA Research Group, Inc.TerminatedBacterial Vaginosis (BV)United States
-
Kaiser PermanenteWithdrawnRecurrent Bacterial VaginosisUnited States
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University of Alabama at BirminghamWayne State UniversityCompletedRecurrent Bacterial VaginosisUnited States
-
Indiana UniversityLupin Pharmaceuticals, Inc.CompletedRecurrent Bacterial VaginosisUnited States
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Douglas KwonRecruiting
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Alfasigma S.p.A.ParexelTerminatedBACTERIAL VAGINOSISUnited States
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Zagazig UniversityUnknownBacterial Vaginosis TreatmentEgypt
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Unity Health TorontoCompleted
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Zagazig UniversityRecruitingBacterial Vaginosis | Vaginal | MicrobiologyEgypt
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Mount Sinai Hospital, CanadaUnity Health TorontoCompletedPregnant Women Who Test Positive for Bacterial VaginosisCanada
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