NCT01020396已完成1 期
A Multi-Center, Double-Blind, Parallel Group Study Comparing the Bioequivalence of Teva Pharmaceuticals, USA's Generic Formulation of Metronidazole Vaginal Gel, 0.75% and MetroGel-Vaginal® Metronidazole Vaginal Gel, 0.75% in the Treatment of Bacterial Vaginosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 579
- 试验地点
- 36
- 主要终点
- Therapeutic cure rate of the subject at the Test-of-Cure Visit.
研究概览
简要总结
The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical equivalence in the treatment of bacterial vaginosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double
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
- •Subjects must provide written informed consent prior to any study related procedures being performed.
- •Female subjects must have a clinical diagnosis of bacterial vaginosis, defined as having the presence of "clue cells" > 20% of the total epithelia cells on microscopic examination of a saline "wet mount" and all of the following criteria: Off-white (milky or grey), thin, homogeneous discharge; pH of vaginal fluid > 4.7; a positive 10% KOH "whiff test".
- •Subjects must be 18 years of age or older with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- •Women of child bearing potential must have a negative urine pregnancy test result upon entry into the study.
- •Subjects must agree to abstain from sexual intercourse throughout the first 7 days of the study. Following the first 7 days, subjects must agree to use a non-lubricated condom when engaging in sexual intercourse.
- •Subjects must be willing to abstain from alcohol ingestion during the 5 day treatment period and for 1 day afterward.
- •Subjects must agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, and diaphragms).
排除标准
- •Subjects with known or suspected other infectious causes of vulvovaginitis (e.g. candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex or human papilloma virus, or any other vaginal or vulvar condition, which in the investigator's opinion, would confound the interpretation of the clinical response).
- •Subjects with a Gram's stain slide Nugent score <
- •Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days of randomization.
- •Subjects who have taken disulfuram within 14 days or randomization.
- •Subjects who have demonstrated a previous hypersensitivity reaction to metronidazole, either orally or topically administered, or any form or parabens.
- •Subjects with primary or secondary immunodeficiency.
- •Women who will be under treatment during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma.
- •Subjects who are pregnant, breast feeding, or planning a pregnancy.
- •Subjects who are menstruating at the time of diagnosis.
- •Subjects with intrauterine devices.
- •Concurrent anticoagulation therapy with coumadin or warfarin.
- •Concurrent use of systemic corticosteroids or systemic antibiotics.
- •Subjects with clinically significant unstable medical disorders, life threatening diseases or current malignancies.
- •Subjects previously enrolled in this study.
- •Subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days.
- •Subjects who are unwilling or unable to comply with the requirements of the protocol.
研究组 & 干预措施
1
Experimental
Metronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA)
干预措施: Metronidazole (Drug)
2
Active Comparator
MetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals)
干预措施: Metronidazole (Drug)
结局指标
主要结局
Therapeutic cure rate of the subject at the Test-of-Cure Visit.
时间窗: Visit 3
Incidence of Adverse Effects reported throughout the study.
时间窗: 29 Days
次要结局
- Therapeutic cure rate at the Post-Treatment Visit(Visit 2)
研究者
研究点 (36)
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