Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
NCT01437722 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205
Last updated 2013-11-20
Summary
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
Conditions
- Recurrent Bacterial Vaginosis (BV)
Interventions
- DRUG
-
1% SPL7013 Gel
vaginal gel
- DRUG
-
3% SPL7013 Gel
vaginal gel
- DRUG
-
placebo gel
vaginal gel
Sponsors & Collaborators
-
Starpharma Pty Ltd
lead INDUSTRY
Principal Investigators
-
Jeremy Paull, PhD · Starpharma Pty Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2012-12-31
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