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Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GDC-229
Metronidazole Vaginal Gel 0.75%
Placebo
Sponsored by
Gage Development Company, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring bacterial vaginosis, vaginal infection, BV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site 103

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test Drug

Reference Drug

Vehicle Placebo Gel

Arm Description

GDC-229 gel applied vaginally as directed.

Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.

GDC-229 Vehicle

Outcomes

Primary Outcome Measures

Clinical Cure
Resolution of clinical signs and symptoms

Secondary Outcome Measures

Full Information

First Posted
March 21, 2017
Last Updated
January 2, 2020
Sponsor
Gage Development Company, LLC
Collaborators
Health Decisions
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1. Study Identification

Unique Protocol Identification Number
NCT03091777
Brief Title
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gage Development Company, LLC
Collaborators
Health Decisions

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
bacterial vaginosis, vaginal infection, BV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
871 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Drug
Arm Type
Experimental
Arm Description
GDC-229 gel applied vaginally as directed.
Arm Title
Reference Drug
Arm Type
Active Comparator
Arm Description
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Arm Title
Vehicle Placebo Gel
Arm Type
Placebo Comparator
Arm Description
GDC-229 Vehicle
Intervention Type
Drug
Intervention Name(s)
GDC-229
Intervention Description
GDC-229 is a vaginal gel.
Intervention Type
Drug
Intervention Name(s)
Metronidazole Vaginal Gel 0.75%
Intervention Description
Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive arm of the study
Primary Outcome Measure Information:
Title
Clinical Cure
Description
Resolution of clinical signs and symptoms
Time Frame
Day 21-30

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Non-pregnant female aged ≥ 18 years who is in good general health
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-pregnant female aged ≥ 18 years who is in good general health Diagnosis of BV 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 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 Able to understand and willing to sign the informed consent form (ICF) and able to comply with the requirements of the protocol Exclusion Criteria: History of alcohol or substance abuse Experienced a clinically significant medical event within 90 days Abnormal pap or high risk human papillomavirus (HPV) 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 Pregnant, lactating, or planning to become pregnant or breastfeed during the study period Primary or secondary immunodeficiency Evidence of any vulvovaginitis at screening other than BV 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 Participating in another clinical trial
Facility Information:
Facility Name
Site 103
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis

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