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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
Vaginal gel, daily for 7 days
Vaginal gel, daily for 7 days
Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
Time frame: Day 9-12
Number of Women With Nugent Cure at the EOT Visit
Nugent Cure is defined as a Nugent score of 0-3 (normal)
Time frame: Day 9-12
Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
Time frame: Day 21-30
Number of Women With Nugent Cure at the TOC Visit
Nugent Cure is defined as a Nugent score of 0-3 (normal)
Time frame: Day 21-30
Adverse Events Potentially Related to Treatment
Number of participants with adverse events considered potentially related to study treatment
Time frame: Screening/baseline through TOC visit, Day 1-30
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