CTRI/2010/091/000238Other3 期
A multicentric, prospective, double-blind, randomized, parallel group study to compare the efficacy, tolerability and safety of Metronidazole gel 0.75% (Zydus) with Metronidazole vaginal gel 0.75% (MetroGel-Vaginal® ) of Graceway Pharmaceuticals, LLC in the treatment of bacterial vaginosis.
适应症
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 670
- 试验地点
- 7
- 主要终点
- The primary efficacy endpoint is the therapeutic cure, which requires both clinical cure and Nugent score of 0-3 at test of cure visit
研究概览
简要总结
This will be a multicentre, double-blind, randomized, parallel group study to compare the efficacy, tolerability and safety of Metronidazole gel 0.75% (Zydus) with MetroGel-Vaginal® Gel, 0.75% (Graceway Pharmaceuticals, LLC) in the treatment of bacterial vaginosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects must provide the written informed consent prior to any study related procedure being performed.
- •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 childbearing 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 seven days of the study.
- •Following the first 7 days, subjects must agree to use adequate contraceptive measures except using lubricated condom when engaging in sexual intercourse.
- •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).
- •Women with regular menstruation and visiting the trial centre from 5th day to 20th day of the cycle or post menopausal women (defined as women with absence of menstruation for at least last 1 year), or women with surgical menopause (oophorectomy, hysterectomy)
- •Subjects must be willing to abstain from alcohol ingestion during first seven days of the study.
- •Female subjects must have a clinical diagnosis of bacterial vaginosis satisfying the following criteria: a) Off-white, thin, homogeneous discharge with little if any inflammation b) pH of vaginal fluid greater than 4.5, using pH paper that measures from 4.0 to 6.0 c) Positive ?whiff?
- •test for amine odour after addition of 10% KOH d) More than or equal to 20% Clue cells of the total epithelial cells on microscopic examination of the saline ?wet mount?
- •A Gram?s stain slide with Nugent score more than equal to 4.
排除标准
- •Known or suspected nonbacterial 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 clinical response).
- •Subject with history of menstrual irregularity in last 3 months.
- •Receipt of antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to dosing.
- •Receipt of disulfiram within 14 days prior to dosing.
- •Previous hypersensitivity reaction to metronidazole in any form or to any form of parabens.
- •History of significant hepatic and/or renal insufficiency
- •Subjects with history of gastrointestinal disease using cimetidine or with history of mental illness using lithium.
- •History of significant cardiovascular disorders
- •History of primary or secondary immunodeficiency.
- •Plans to be treated during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma.
- •Pregnant, nursing mothers or any subject planning a pregnancy within the next 2 months.
- •Concurrent anticoagulation therapy with Coumadin (e.g. warfarin).
- •Concurrent use of systemic corticosteroids or systemic antibiotics.
- •Participation in another clinical trial or having taken an experimental drug within 30 days prior to the study entry.
结局指标
主要结局
The primary efficacy endpoint is the therapeutic cure, which requires both clinical cure and Nugent score of 0-3 at test of cure visit
时间窗: 21-30 days
次要结局
- The secondary efficacy endpoints are(a)Clinical cure rate)
研究者
研究点 (7)
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