Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.

Study Overview

• Status: Completed
• Conditions: Vaginosis, Bacterial; Vaginal Infection
• Intervention / Treatment: Drug: GW05; Drug: GW05; Drug: GW05; Drug: Metronidazole

Detailed Description

This is a multicenter, randomized, investigator-blinded, phase 2, dose ranging study of GW05 vaginal gel administered in 3 regimens compared to metronidazole 0.75% (QD x 5 days) for the treatment of bacterial vaginosis. Subjects will be evaluated at three timepoints (1 screening/baseline visit, post-treatment phone call and 1 test-of-cure visit). The total study duration may be up to 30 days for a subject.

Study medication will be applied intravaginally once daily at bedtime according to the assigned dosing schedule using the supplied 5-gram vaginal applicators.

Investigator blinding will be ensured by utilizing an independent drug dispensing coordinator at each site.

Bacterial vaginosis (BV) is an infection of the vagina (birth canal) that is the result of an overgrowth of bacteria that are often normally found in the vagina. This type of vaginal infection typically does not cause irritation. The most common complaint of patients who suffer from BV is a fishy-smelling vaginal discharge. The amount of vaginal discharge may or may not be increased above a normal discharge. The bad odor may get worse after sexual intercourse or during the menstrual period. BV is also strongly associated with problems during pregnancy, such as premature (early) birth, and with an increased risk of sexually transmitted diseases. Therefore, it is important to treat the infection.

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Women's Health Research
    • Phoenix, Arizona, United States, 85032
      • Precision Trials
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Women's Clinic
  • California
    • San Diego, California, United States, 92123
      • Women's Health Center Inc
  • Colorado
    • Denver, Colorado, United States, 80218
      • Downtown Women's Healthcare
  • Florida
    • Miami, Florida, United States, 33143
      • Miami Research Associates
    • North Miami, Florida, United States, 33161
      • Segal Institiute for Clinical Research
    • Plantation, Florida, United States, 33324
      • All Women's Healthcare of West Broward
  • Georgia
    • Roswell, Georgia, United States, 30075
      • Atlanta North Gynecology
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Women's Health Practice
  • Massachusetts
    • Haverhill, Massachusetts, United States, 01830
      • ActivMed Practices & Research
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Grand Rapids Women's Health
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research Group
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
      • Women's Health Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Jackson Clinic
    • Memphis, Tennessee, United States, 38120
      • Adams Patterson OBGYN
  • Texas
    • Austin, Texas, United States, 78705
      • Women's Partners in Health
    • Houston, Texas, United States, 77054
      • TMC Life Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Physicians for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females at least 18 years of age
• In good general health
• Confirmed current diagnosis of bacterial vaginosis (determined at study screening)
• Negative pregnancy test (for women who are able to become pregnant)
• Must abstain from sexual intercourse throughout the first 7 days of thes study
• Must abstain from alcohol ingestion during the treatment period and for one day afterward
• Must not use intra-vaginal products for the duration of the study

Exclusion Criteria:

• Pregnant, lactating, or planning to become pregnant during the study period
• Menstruating at the time of the diagnosis or anticipate the onset of menses during the treatment phase of the study
• Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.)
• Received specific treatments/medications /therapy within the designated time period prior to study enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metronidazole	Drug: Metronidazole; vaginal gel 0.75% once daily for 5 days
Active Comparator: 1D	Drug: GW05; vaginal gel once daily regimen A; Drug: GW05; vaginal gel once daily regimen B; Drug: GW05; vaginal gel once daily regimen C
Active Comparator: 3D	Drug: GW05; vaginal gel once daily regimen A; Drug: GW05; vaginal gel once daily regimen B; Drug: GW05; vaginal gel once daily regimen C
Active Comparator: 5D	Drug: GW05; vaginal gel once daily regimen A; Drug: GW05; vaginal gel once daily regimen B; Drug: GW05; vaginal gel once daily regimen C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of subjects with therapeutic cure	day 21 to day 30

Collaborators and Investigators

• Sponsor: Graceway Pharmaceuticals, LLC
• Investigators: Study Director: Sharon F Levy, MD, Graceway Pharmaceuticals

Publications and helpful links

General Publications

• Chavoustie SE, Jacobs M, Reisman HA, Waldbaum AS, Levy SF, Hillier SL, Nyirjesy P. Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study. J Low Genit Tract Dis. 2015 Apr;19(2):129-34. doi: 10.1097/LGT.0000000000000062.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: January 21, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 25, 2010

Study Record Updates

• Last Update Posted (Estimate): July 1, 2011
• Last Update Submitted That Met QC Criteria: June 28, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: bacterial vaginosis; vaginal discharge; vaginal infection; vaginal disease
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: GW05-0904