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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091777
• Other study ID #: GDC-229-002
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

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