A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,251
- 试验地点
- 125
- 主要终点
- Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4
研究概览
简要总结
This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
- •Be a female of any race between the ages of 45-65 years, in generally good health,
- •Be either naturally or surgically postmenopausal (with or without a uterus)
排除标准
- •Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
- •History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study
研究组 & 干预措施
1
干预措施: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)
2
干预措施: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)
3
干预措施: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)
4
干预措施: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)
5
干预措施: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)
6
干预措施: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)
7
干预措施: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)
8
干预措施: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)
9
干预措施: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)
结局指标
主要结局
Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4
时间窗: 4 weeks
Mean change in frequency of moderate to severe VMS from baseline to Week 12
时间窗: 12 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 4
时间窗: 4 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 12
时间窗: 12 weeks
次要结局
- Frequency and severity of moderate to severe and all hot flushes at each week(12 weeks)
- Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome(12 weeks)
- Mean change from baseline to Week 12 in vaginal pH(12 weeks)
- Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)(12 weeks)