Overview

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

Status:
Completed
Trial end date:
2017-02-22
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 of the 4 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