NCT01724658已完成2 期
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- female sexual function index score
研究概览
简要总结
Additional testosterone undecanoate can improve female sexual function in postmenopausal women which one aspects of quality of life. The dose adjustment can reduce incidence of adverse effects and low cost of treatment with effective outcome.
详细描述
Research Question:
" Does oral testosterone undecanoate improve sexual problem in postmenopausal women? " Type Research:Clinical research
Study design:
Randomized double-blinded placebo controlled trial
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •postmenopausal women with age between 40-60 years
- •Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5
排除标准
- •women with previous use of hormonal replacement or anti-psychiatric drugs within 3 months
- •women with history of or present premalignancies/malignancies
- •women present with liver disease or abnormal liver enzyme
- •women with active cardiovascular, cerebrovascular or thromboembolic disorders
- •women with Present psychiatric disease
- •Partner have sexual dysfunction
研究组 & 干预措施
Testosterone undecanoate
Experimental
testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily
干预措施: Testosterone undecanoate (Drug)
placebo
Placebo Comparator
placebo twice a week with progynova 1 mg oral daily
干预措施: placebo (Drug)
结局指标
主要结局
female sexual function index score
时间窗: 8 weeks
次要结局
- adverse effects of the drug(8 week)
研究者
研究点 (1)
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