Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- McCoy's sexual questionnaire
研究概览
简要总结
Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual life and life quality. These effects can be counteracted by administration of estrogen therapy. However, estrogen therapy has side effects and isoflavone has been proposed as an estrogen substitute in reposition therapy. The aim of the randomized controlled trial is to evaluate the effects of isoflavone in the sex life assessed by a modified McCoy's sexual questionnaire.
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
- 是
入选标准
- •women aged 45-65 years old
- •presenting climacteric symptoms
- •sexual complaints
排除标准
- •hormonal therapy
- •counter indication to hormonal therapy
- •uncontrolled comorbidities
研究组 & 干预措施
Estrogen
Women randomized to this group will receive daily pills containing 1 mg of estradiol
干预措施: estradiol (Drug)
Isoflavone
Women randomized to this group will receive daily pills of 150 mg isoflavone
干预措施: isoflavone (Drug)
Placebo
Women randomized to this group will be administered daily placebo pills
干预措施: Placebo (Drug)
结局指标
主要结局
McCoy's sexual questionnaire
时间窗: at recruitment and six months later
次要结局
- Kupperman's index(at recruitment and six months later)