Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

• Status: Completed
• Trial end date: 2016-10-04
• Target enrollment: 0
• Participant gender: Female

Summary

A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Starpharma Pty Ltd
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• Current active episode of BV (diagnosis defined as: at least 3 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)

• History of recurrent BV (at least 3 episodes in previous year including current episode)

• Using an effective method of contraception

Exclusion Criteria:

• Test positive for a sexually transmitted infection

• Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment

• Abnormal pelvic exam, including presence of other vaginal or urinary tract infections

• Pregnancy