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

PHASE3CompletedINTERVENTIONAL
Enrollment

637

Participants

Timeline

Start Date

October 3, 2014

Primary Completion Date

July 4, 2016

Study Completion Date

October 4, 2016

Conditions
Bacterial Vaginosis
Interventions
DRUG

Metronidazole oral tablets 500mg

One tablet taken orally twice daily for seven consecutive days

DRUG

1% SPL7013 Gel

5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.

DRUG

Placebo gel

5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Trial Locations (30)

27103

Lyndhurst Clinical Research, Winston-Salem

70001

Southern Clinical Research Associates, Metairie

85032

Precision Trials, LLC, Phoenix

92108

Medical Center for Clinical Research, San Diego

Unknown

Sites Various, Pleven

Sites Various, Plovidiv

Sites Various, Sofia

Sites Various, Stara Zagora

Sites Various, Brno

Sites Various, České Budějovice

Sites Various, Olomouc

Sites Various, Písek

Sites Various, Prague

Sites Various, Vsetín

Sites Various, Baja

Sites Various, Balatonfüred

Sites Various, Budapest

Sites Various, Debrecen

Sites Various, Gyömrő

Sites Various, Komárom

Sites Various, Létavértes

Sites Various, Zalaegerszeg

Sites Various, Ivano-Frankivsk

Sites Various, Kyiv

Sites Various, Zaporizhzhia

Sites Various, Birmingham

Sites Various, Coventry

Sites Various, Leeds

Sites Various, London

Sites Various, Plymouth

All Listed Sponsors
lead

Starpharma Pty Ltd

INDUSTRY

NCT02236156 - Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) | Biotech Hunter | Biotech Hunter