Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
Phase 2
Completed
- Conditions
- Recurrent Bacterial Vaginosis (BV)
- Interventions
- Drug: 1% SPL7013 GelDrug: 3% SPL7013 GelDrug: placebo gel
- Registration Number
- NCT01437722
- Lead Sponsor
- Starpharma Pty Ltd
- Brief Summary
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 205
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1% SPL7013 Gel 1% SPL7013 Gel - 3% SPL7013 Gel 3% SPL7013 Gel - placebo gel placebo gel -
- Primary Outcome Measures
Name Time Method Number of women who have experienced a recurrent episode of BV as a measure of efficacy Day 112 +/- 5 Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria
- Secondary Outcome Measures
Name Time Method