NCT00755053已完成3 期
An Investigator-blinded, Active-controlled Phase 3 Study to Prove the Non-inferior Efficacy of a Clotrimazole Ovule (500 mg) Versus a Clotrimazole Vaginal Tablet (500 mg) in Vaginal Candidiasis
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
- Bayer
- 入组人数
- 466
- 主要终点
- Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
研究概览
简要总结
The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
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
- Single (Investigator)
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years.
- •Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation).
- •Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition.
- •Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
- •Negative saline smear for Trichomonas vaginalis
排除标准
- •Subjects with known hypersensitivity to imidazoles or triazoles and their analogues.
- •Subjects presenting a protozoan infection as confirmed by microscopic investigation.
- •Pregnant, breast feeding or lactating subjects.
- •Subjects with suspected bacterial vaginal infection.
- •Subjects with abdominal pain, fever, or foul smelling vaginal discharge.
- •Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit
- •Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial.
- •Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4).
- •Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4).
- •Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2).
- •Subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months.
- •Subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections.
- •Subjects who received another investigational drug within 30 days before visit
- •Unwillingness to refrain from sexual activity during 3 days thereafter.
- •Actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.
研究组 & 干预措施
Clotrimazole tablet (Canesten, BAY-B5097)
Active Comparator
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
干预措施: Clotrimazole, vaginal tablet (Drug)
Clotrimazole ovule (Canesten, BAY-B5097)
Experimental
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
干预措施: Clotrimazole, vaginal ovule (Drug)
结局指标
主要结局
Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
时间窗: 10-14 days after treatment (=visit 2)
次要结局
- Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)(6-8 weeks after treatment (=visit 3))
- Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)(10-14 days after treatment (=visit 2))
- Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)(6-8 weeks after treatment (=visit 3))
- Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)(10-14 days after treatment (=visit 2))
- Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)(6-8 weeks after treatment (=visit 3))
研究者
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