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

PHASE3CompletedINTERVENTIONAL
Enrollment

586

Participants

Timeline

Start Date

October 13, 2014

Primary Completion Date

December 9, 2016

Study Completion Date

February 22, 2017

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 (45)

19114

Clinical Research of Philadelphia, Philadelphia

23225

Clinical Trials of Virginia, Richmond

27518

PMG Research of Cary, LLC, Cary

28144

PMG Research of Salisbury, Salisbury

29621

Clinical Research Advantage, Anderson

30041

Atlanta Medical Research Institute, Alpharetta

30067

Urban Family Practice Associates, Marietta

33016

The Community Research South Florida, Hialeah

33141

Community Medical Research, Miami Beach

33142

Florida Medical Center and Research Inc., Miami

33173

Research Institute of South Florida, Miami

33409

Comprehensive Clinical Trials, West Palm Beach

35233

University of Alabama, Birmingham

36117

Montgomery Women's Health Associates, Montgomery

37404

Chattanooga Medical Research, Chattanooga

37920

Volunteer Research Group, Knoxville

38104

Women's Physician Group, Memphis

43212

Radiant Research, Columbus

44311

Radiant Research, Akron

49079

Women's Healthcare Specialists, Paw Paw

49425

Medical University of South Carolina, Charleston

67114

Heartland Research Associates, LLC, Newton

68154

Alegent Creighton Health, Omaha

68510

Women's Clinic of Lincoln, PC, Lincoln

72205

Lynn Institute of the Ozarks, Little Rock

73069

Lynn Institute of Norman, Norman

73112

Lynn Health Science Institute, Oklahoma City

75230

Practice Research Organization, Dallas

78229

Radiant Research, San Antonio

80209

Downtown Women's Health Care, Denver

80907

Lynn Institute of the Rockies, Colorado Springs

84088

Jordan River Family Medicine, South Jordan

89105

Affiliated Clinical Research, Las Vegas

92114

Precision Research Institute, San Diego

92123

Women's Health Care, San Diego

98105

Women's Clinical Research Center, Seattle

08648

Lawrence OB-GYN Associates, Lawrenceville

N2G1H6

Medicine Professional Corporation, Kitchener

L3Y5G8

SKDS Research Inc, Newmarket

N955C6

Healthy Image Centre, Windsor

H4N3C5

DIEX Recherche Montreal Inc, Montreal

J1H1Z1

DIEX Recherche Sherbrooke Inc., Sherbrooke

00917

Torre Auxillo Mutuo, Hato Rey

00918

Latin Clinical Trial Center, San Juan

Unknown

University of Puerto Rico, San Juan

All Listed Sponsors
lead

Starpharma Pty Ltd

INDUSTRY

NCT02237950 - Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) | Biotech Hunter | Biotech Hunter