Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Starpharma Pty Ltd

Criteria

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.