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

NCT02236156

Run by

Starpharma Pty Ltd

People needed

637

Starts

2014-10-03

Expected to finish

2016-10-04

Last updated by the study team

2018-06-25

Who can join

Age: 18 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 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

• Precision Trials, LLC — Phoenix, Arizona, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Southern Clinical Research Associates — Metairie, Louisiana, United States
• Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• Sites Various — Pleven, Bulgaria
• Sites Various — Plovidiv, Bulgaria
• Sites Various — Sofia, Bulgaria
• Sites Various — Stara Zagora, Bulgaria
• Sites Various — Brno, Czechia
• Sites Various — České Budějovice, Czechia
• Sites Various — Olomouc, Czechia
• Sites Various — Písek, Czechia
• Sites Various — Prague, Czechia
• Sites Various — Vsetín, Czechia
• Sites Various — Baja, Hungary
• Sites Various — Balatonfüred, Hungary
• Sites Various — Budapest, Hungary
• Sites Various — Debrecen, Hungary
• Sites Various — Gyömrő, Hungary
• Sites Various — Komárom, Hungary
• Sites Various — Létavértes, Hungary
• Sites Various — Zalaegerszeg, Hungary
• Sites Various — Ivano-Frankivsk, Ukraine
• Sites Various — Kyiv, Ukraine
• Sites Various — Zaporizhzhya, Ukraine

Full record on ClinicalTrials.gov

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