CompletedPhase 3

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

United States586 participantsStarted 2014-10-13

Plain-language 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.

Who can participate

Age range16 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings

Timeframe: At or by the Week 16 visit

Trial details

NCT IDNCT02237950

SponsorStarpharma Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-09

Results submitted2019-05-07

View on ClinicalTrials.gov More Bacterial Vaginosis trials