Conditions: Bacterial Vaginosis
Keywords: SPL7013 VivaGel bacterial vaginosis BV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 250
Healthy volunteers: no

Brief summary:
The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).

After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: 1% SPL7013 Gel intervention 2: Placebo
Intervention descriptions: intervention 1: Vaginal gel, daily for 7 days intervention 2: Vaginal gel, daily for 7 days

Protocol document: