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Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% 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: NCT03091777
Recruitment Status : Completed
First Posted : March 27, 2017
Results First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Health Decisions
Information provided by (Responsible Party):
Gage Development Company, LLC

Brief Summary:
This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: GDC-229 Drug: Metronidazole Vaginal Gel 0.75% Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 871 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Vehicle Controlled Study Evaluating the Therapeutic Equivalence and Safety of GDC-229 (Investigational Metronidazole 0.75% Vaginal Gel) and Metronidazole 0.75% Vaginal Gel in the Treatment of Bacterial Vaginosis
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : March 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: Test Drug
GDC-229 gel applied vaginally as directed.
Drug: GDC-229
GDC-229 is a vaginal gel.

Active Comparator: Reference Drug
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Drug: Metronidazole Vaginal Gel 0.75%
Metronidazole Vaginal Gel 0.75% is an FDA-approved drug

Placebo Comparator: Vehicle Placebo Gel
GDC-229 Vehicle
Drug: Placebo
Inactive arm of the study




Primary Outcome Measures :
  1. Clinical Cure [ Time Frame: Day 21-30 ]
    Resolution of clinical signs and symptoms



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
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Non-pregnant female aged ≥ 18 years who is in good general health
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Non-pregnant female aged ≥ 18 years who is in good general health
  2. Diagnosis of BV
  3. Willing to refrain from using any intravaginal product (e.g., spermicide, tampon, douche, feminine deodorant spray, diaphragm, vaginal ring birth control, or condom with spermicide or insertion into the vagina of any drug or non-drug product during treatment), other than study treatment for the duration of the trial
  4. Subjects of childbearing potential who have a negative urine pregnancy test at the Entry Visit (Visit 1) and agree to use an acceptable form of birth control throughout the study
  5. Able to understand and willing to sign the informed consent form (ICF) and able to comply with the requirements of the protocol

Exclusion Criteria:

  1. History of alcohol or substance abuse
  2. Experienced a clinically significant medical event within 90 days
  3. Abnormal pap or high risk human papillomavirus (HPV)
  4. History or presence of clinically significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, gynecologic, dermatologic, neurologic, oncologic, or psychiatric disease
  5. Pregnant, lactating, or planning to become pregnant or breastfeed during the study period
  6. Primary or secondary immunodeficiency
  7. Evidence of any vulvovaginitis at screening other than BV
  8. History of hypersensitivity or allergy to metronidazole, parabens, other nitroimidazole derivatives, or other ingredients of the GDC 229 (metronidazole 0.75% vaginal gel), metronidazole 0.75% vaginal gel (Oceanside Pharmaceuticals), or vehicle gel
  9. Participating in another clinical trial

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): NCT03091777


Locations
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United States, North Carolina
Site 103
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Gage Development Company, LLC
Health Decisions
  Study Documents (Full-Text)

Documents provided by Gage Development Company, LLC:
Study Protocol  [PDF] January 24, 2017
Statistical Analysis Plan  [PDF] February 16, 2018


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Responsible Party: Gage Development Company, LLC
ClinicalTrials.gov Identifier: NCT03091777     History of Changes
Other Study ID Numbers: GDC-229-002
First Posted: March 27, 2017    Key Record Dates
Results First Posted: October 14, 2019
Last Update Posted: October 14, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gage Development Company, LLC:
bacterial vaginosis
vaginal infection
BV
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents