CTRI/2014/05/004586招募中3 期
An assessor blind, parallel, multicentric randomized placebo-controlled study to demonstrate the efficacy and safety of Estradiol 10μg (Test product: Manufactured by Famy Care Ltd., India) with Vagifem® (Reference drug: Manufactured by Novo Nordisk Inc., USA) in healthy postmenopausal women with symptoms of vulvar and vaginal atrophy and no contraindication to estrogen therapy. - NA
Famy Care Ltd0 个研究点目标入组 465 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 465
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
入选标准
- •Patient should be able to give written informed consent
- •Patients should be Postmenopausal women with vaginal atrophy
- •At screening systolic blood pressure be no greater than 150 mm Hg and diastolic blood pressure be no greater than 90 mm Hg
- •Patient with no significant illness other than vaginal atrophy as judged by the Investigator
- •Ability to comply with requirements of trial
排除标准
- •Known or suspected allergy to estrogen or any of its excipients
- •Known or suspected history of breast carcinoma, Estrogen-dependent neoplasia
- •Genital bleeding of unknown cause
- •Acute thrombophlebitis or thromboembolic disorder associated with estrogen use
- •Known history of drug or alcohol abuse
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