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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT02237950

Run by

Starpharma Pty Ltd

People needed

586

Starts

2014-10-13

Expected to finish

2017-02-22

Last updated by the study team

2019-07-22

Who can join

Age: 16 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Montgomery Women's Health Associates — Montgomery, Alabama, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Precision Research Institute — San Diego, California, United States
• Women's Health Care — San Diego, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Downtown Women's Health Care — Denver, Colorado, United States
• The Community Research South Florida — Hialeah, Florida, United States
• Florida Medical Center and Research Inc. — Miami, Florida, United States
• Research Institute of South Florida — Miami, Florida, United States
• Community Medical Research — Miami Beach, Florida, United States
• Comprehensive Clinical Trials — West Palm Beach, Florida, United States
• Atlanta Medical Research Institute — Alpharetta, Georgia, United States
• Urban Family Practice Associates — Marietta, Georgia, United States
• Heartland Research Associates, LLC — Newton, Kansas, United States
• Women's Healthcare Specialists — Paw Paw, Michigan, United States
• Women's Clinic of Lincoln, PC — Lincoln, Nebraska, United States
• Alegent Creighton Health — Omaha, Nebraska, United States
• Affiliated Clinical Research — Las Vegas, Nevada, United States
• Lawrence OB-GYN Associates — Lawrenceville, New Jersey, United States
• PMG Research of Cary, LLC — Cary, North Carolina, United States
• PMG Research of Salisbury — Salisbury, North Carolina, United States
• Radiant Research — Akron, Ohio, United States
• Radiant Research — Columbus, Ohio, United States
• Lynn Institute of Norman — Norman, Oklahoma, United States

Full record on ClinicalTrials.gov

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