NCT03091777已完成3 期
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
Balmoral Medical company1 个研究点 分布在 1 个国家目标入组 871 人开始时间: 2017年3月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 871
- 试验地点
- 1
- 主要终点
- Clinical Cure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Test Drug
Experimental
GDC-229 gel applied vaginally as directed.
干预措施: GDC-229 (Drug)
Reference Drug
Active Comparator
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
干预措施: Metronidazole Vaginal Gel 0.75% (Drug)
Vehicle Placebo Gel
Placebo Comparator
GDC-229 Vehicle
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Cure
时间窗: Day 21-30
Resolution of clinical signs and symptoms
次要结局
未报告次要终点
研究者
研究点 (1)
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