EUCTR2007-002939-90-FI进行中（未招募）1 期
Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 mg Oral Daily Dose of Ospemifene with Placebo - 52 wks VVA study
Hormos Medical Ltd0 个研究点目标入组 350 人开始时间: 2007年6月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •The subject is a woman 40 to 80 years old at the time of randomization.
- •The subject is postmenopausal.
- •Subject has an intact uterus.
- •The subject has 5% or fewer superficial cells in the maturation index of the vaginal smear
- •The subject has vaginal pH greater than 5.0
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has double-layer endometrial thickness =4 mm on endometrial ultrasound at screening.
- •Subject has evidence of hyperplasia, cancer or other pathology from the endometrial biopsy at screening.
- •Subject has abnormal Papanicolaou test result at screening.
- •Subject has clinically significant abnormal gynecological findings other than signs of vaginal atrophy.
- •Subject has taken certain hormonal medications (lited in protocol).
- •Subject has taken selective estrogen receptor modulator (SERM) or any other medications that are expected to have clinically significant estrogenic and/or antiestrogenic effects within 60 days prior to screening.
- •Subject has clinically significant abnormal findings at physical examination at screening.
- •Subject is heterozygous or homozygous for Factor V Leiden (test done at screening).
- •Subject has current or history of thromboembolic or blood coagulation disorder.
- •Subject has current or history of cerebrovascular incident.
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