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
About this trial
This is an interventional treatment trial for Bacterial Vaginosis focused on measuring bacterial vaginosis, vaginal infection, BV
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
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
NCT ID
NCT03091777
First Posted
March 21, 2017
Last Updated
January 2, 2020
Sponsor
Gage Development Company, LLC
Collaborators
Health Decisions
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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