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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT03091777

Run by

Balmoral Medical company

People needed

871

Starts

2017-03-10

Expected to finish

2018-03-27

Last updated by the study team

2020-01-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Site 103 — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.