Status:
COMPLETED
Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
Lead Sponsor:
Starpharma Pty Ltd
Conditions:
Recurrent Bacterial Vaginosis (BV)
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT01437722
Start Date
August 1 2011
Last Update
November 20 2013
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