Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV) (NCT01437722) | Clinical Trial Compass
CompletedPhase 2
Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
205 participantsStarted 2011-08
Plain-language summary
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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.
What they're measuring
1
Number of women who have experienced a recurrent episode of BV as a measure of efficacy