NCT01055106

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

January 21, 2010

Last Update Submit

June 28, 2011

Conditions

Vaginosis, BacterialVaginal Infection

Keywords

bacterial vaginosisvaginal infectionvaginal dischargevaginal disease

Outcome Measures

Primary Outcomes (1)

  • proportion of subjects with therapeutic cure

    day 21 to day 30

Study Arms (4)

1D

ACTIVE COMPARATOR
Drug: GW05

3D

ACTIVE COMPARATOR
Drug: GW05

5D

ACTIVE COMPARATOR
Drug: GW05

Metronidazole

ACTIVE COMPARATOR
Drug: Metronidazole

Interventions

GW05DRUG

vaginal gel once daily regimen A

1D
MetronidazoleDRUG

vaginal gel 0.75% once daily for 5 days

Metronidazole

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

Precision Trials

Phoenix, Arizona, 85032, United States

Location

NEA Women's Clinic

Jonesboro, Arkansas, 72401, United States

Location

Women's Health Center Inc

San Diego, California, 92123, United States

Location

Downtown Women's Healthcare

Denver, Colorado, 80218, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Segal Institiute for Clinical Research

North Miami, Florida, 33161, United States

Location

All Women's Healthcare of West Broward

Plantation, Florida, 33324, United States

Location

Atlanta North Gynecology

Roswell, Georgia, 30075, United States

Location

Women's Health Practice

Champaign, Illinois, 61820, United States

Location

ActivMed Practices & Research

Haverhill, Massachusetts, 01830, United States

Location

Grand Rapids Women's Health

Grand Rapids, Michigan, 49503, United States

Location

Saginaw Valley Medical Research Group

Saginaw, Michigan, 48604, United States

Location

Women's Health Research Center

Plainsboro, New Jersey, 08536, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

Adams Patterson OBGYN

Memphis, Tennessee, 38120, United States

Location

Women's Partners in Health

Austin, Texas, 78705, United States

Location

TMC Life Research

Houston, Texas, 77054, United States

Location

Tidewater Physicians for Women

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

  • 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.

    PMID: 24983350DERIVED

MeSH Terms

Conditions

Vaginosis, BacterialVaginitisVaginal DischargeVaginal Diseases

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sharon F Levy, MD

    Graceway Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 25, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations

US(20)