EUCTR2006-005071-17-FI进行中（未招募）不适用
Preliminary efficacy of OphenaTM (ospemifene) in the treatment of vasomotor symptoms associated with the menopause: a 6-week, randomized, double-blind, placebo-controlled, parallel-group study - Hotflash-study
Hormos Medical Ltd0 个研究点开始时间: 2006年10月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 70 years old at the time of randomization.
- •The subject is postmenopausal. Postmenopausal is defined as
- •at least 12 months since the last spontaneous menstrual bleeding and
- •serum FSH levels > 40 IU/L and estradiol = 0.20 nmol/mL or
- •hysterectomy with intact ovaries and serum FSH levels > 40 IU/L and
- •estradiol = 0.20 nmol/L or
- •at least 6 weeks post- surgical bilateral oophorectomy.
- •The subject has at least 7 moderate, severe, or very severe hot flashes per day or 50 per week recorded for seven consecutive days. This information will be confirmed on the screening diary.
- •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 taken certain hormonal medications (listed in protocol).
- •Subject has clinically significant abnormal gynecological findings other than vaginal atrophy at screening.
- •Subject has taken a selective estrogen receptor modulator (SERM) within 60 days prior to screening
- •Subject has clinically relevant abnormal findings in any safety laboratory tests.
- •Subject has current or history of thromboembolic or blood coagulation disorder.
- •Subject has current or history of cerebrovascular incident
研究者
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