NCT01452373已完成3 期
DHEA + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women (Placebo Controlled, Double Blind and Randomized Phase III Study to Evaluate the Effects of 12-Week Treatment With DHEA (Prasterone) and Acolbifene on Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 15
- 主要终点
- Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.
研究概览
简要总结
The purpose of this Phase III trial is to evaluate the efficacy of oral administration of dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (non-hysterectomized or hysterectomized).
- •Women between 40 and 75 years of age.
- •Willing to participate in the study and sign an informed consent.
- •Women having many moderate to severe hot flushes.
- •For non-hysterectomized women, willing to have an endometrial biopsy at baseline and end of-study.
排除标准
- •Undiagnosed abnormal genital bleeding.
- •Hypertension equal to or above 140/90 mm Hg.
- •The administration of any investigational drug within 30 days of screening visit.
- •Endometrial hyperplasia (simple or complex hyperplasia with or without atypia), cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
研究组 & 干预措施
Control (placebo)
Placebo Comparator
干预措施: Placebo (Drug)
DHEA + Acolbifene
Experimental
干预措施: DHEA and Acolbifene (Drug)
结局指标
主要结局
Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.
时间窗: 12 weeks
Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.
时间窗: 12 weeks
次要结局
- Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).(12 weeks)
- Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.(12 weeks)
- Tolerance to systemic administration of DHEA and acolbifene.(12 weeks)
研究者
研究点 (15)
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