ISRCTN64791295已完成不适用
A phase III, single-blind, single-centre trial to assess efficacy and tolerability of genital mucosa after use of product INC056 in post-menopausal women
Incrementha PD&I (Brazil)0 个研究点目标入组 65 人开始时间: 2008年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Healthy female volunteers aged between 40 and 65 years
- •2. Post-menopausal women
- •3. Vaginal pH of 5.0 or higher
- •4. Written informed consent
排除标准
- •1. Pregnancy or lactation
- •2. Skin disease at site of administration
- •3. Diabetes mellitus
- •4. Immunological insufficiency
- •5. Use of systemic corticoid, antibiotics or steroids
- •6. Use of immunosuppressive drugs
- •7. Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis
- •8. Antifungal therapy within the last month at screening
- •9. History of infection at the site of drug administration
- •10. History of allergies to components of product
- •11. Other diseases or medications that could interfere with the research result or endanger the volunteer
研究者
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