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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01055106
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : July 1, 2011
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC

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.

Condition or disease Intervention/treatment Phase
Vaginosis, Bacterial Vaginal Infection Drug: GW05 Drug: Metronidazole Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
Study Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Active Comparator: 1D Drug: GW05
vaginal gel once daily regimen A

Active Comparator: 3D Drug: GW05
vaginal gel once daily regimen B

Active Comparator: 5D Drug: GW05
vaginal gel once daily regimen C

Active Comparator: Metronidazole Drug: Metronidazole
vaginal gel 0.75% once daily for 5 days




Primary Outcome Measures :
  1. proportion of subjects with therapeutic cure [ Time Frame: day 21 to day 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055106


Locations
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Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
Investigators
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Study Director: Sharon F Levy, MD Graceway Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sharon F. Levy, MD / Vice President Product Develpoment, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01055106    
Other Study ID Numbers: GW05-0904
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: June 2011
Keywords provided by Graceway Pharmaceuticals, LLC:
bacterial vaginosis
vaginal infection
vaginal discharge
vaginal disease
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Infections
Bacterial Infections
Bacterial Infections and Mycoses
Vaginitis
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents