Overview

A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Status:
Completed
Trial end date:
2012-07-20
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Starpharma Pty Ltd
Criteria
Key eligibility criteria:

- Post-menarchal females, aged 12 years or more

- Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms:
presence of white to grey homogeneous discharge; positive whiff test indicating an
amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5;
and presence at least 20% clue cells of total epithelial cells

- Nugent score of at least 4

- Otherwise healthy, as determined by medical history, physical examination

- normal Pap smear at or documented within 24 months of screening