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

NCT03091777 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GDC-229-002
• Study Type: interventional
• Target: 871
• Locations: 1 country
• Sites: 1

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

Keywords

bacterial vaginosis; vaginal infection; BV

Outcome Measures

Primary Outcomes (1)

• Clinical Cure

  Resolution of clinical signs and symptoms

  Day 21-30

Study Arms (3)

Test Drug

EXPERIMENTAL

GDC-229 gel applied vaginally as directed.

Drug: GDC-229

Reference Drug

ACTIVE COMPARATOR

Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.

Drug: Metronidazole Vaginal Gel 0.75%

Vehicle Placebo Gel

PLACEBO COMPARATOR

GDC-229 Vehicle

Drug: Placebo

Interventions

GDC-229 DRUG

GDC-229 is a vaginal gel.

Test Drug

Metronidazole Vaginal Gel 0.75% DRUG

Metronidazole Vaginal Gel 0.75% is an FDA-approved drug

Reference Drug

Placebo DRUG

Inactive arm of the study

Vehicle Placebo Gel

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Non-pregnant female aged ≥ 18 years who is in good general health
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balmoral Medical company: lead
• Premier Research: collaborator

Study Sites (1)

Site 103

Raleigh, North Carolina, 27612, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Vaginitis

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Gage Development Company
• Organization: Gage Development Company

clinicalinfo@capstonedevservices.com

1-847-999-0600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: March 10, 2017
• Primary Completion: November 15, 2017
• Study Completion: March 27, 2018
• Last Updated: January 7, 2020
• Results First Posted: October 14, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)