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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03091777
Other study ID # GDC-229-002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 10, 2017
Est. completion date March 27, 2018

Study information

Verified date September 2019
Source Gage Development Company, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 871
Est. completion date March 27, 2018
Est. primary completion date November 15, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
GDC-229
GDC-229 is a vaginal gel.
Metronidazole Vaginal Gel 0.75%
Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
Placebo
Inactive arm of the study

Locations

Country Name City State
United States Site 103 Raleigh North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Gage Development Company, LLC Health Decisions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Cure Resolution of clinical signs and symptoms Day 21-30
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