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

NCT ID: NCT03091777

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 871 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-10
• Study Completion Date: 2018-03-27

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.

Conditions

Bacterial Vaginosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test Drug

GDC-229 gel applied vaginally as directed.

Group Type: EXPERIMENTAL

GDC-229

Intervention Type: DRUG

GDC-229 is a vaginal gel.

Reference Drug

Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.

Group Type: ACTIVE_COMPARATOR

Metronidazole Vaginal Gel 0.75%

Intervention Type: DRUG

Metronidazole Vaginal Gel 0.75% is an FDA-approved drug

Vehicle Placebo Gel

GDC-229 Vehicle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive arm of the study

Interventions

GDC-229

GDC-229 is a vaginal gel.

Intervention Type: DRUG

Metronidazole Vaginal Gel 0.75%

Metronidazole Vaginal Gel 0.75% is an FDA-approved drug

Intervention Type: DRUG

Placebo

Inactive arm of the study

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Premier Research

OTHER

Sponsor Role: collaborator

Balmoral Medical company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 103

Raleigh, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GDC-229-002

Identifier Type: -

Identifier Source: org_study_id