A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 52 Weeks and Safety for 52 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 610
- 试验地点
- 1
- 主要终点
- To assess the efficacy of the transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL).
研究概览
简要总结
This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin therapy.
详细描述
Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients were stratified based on presence/absence of uterus and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen/progestin throughout the study. Patients who completed the first 52 weeks of the study were given the opportunity to participate in year 2-4 open-label (active treatment) study extension which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabois in evaluation, coagulation testing, and hermatology. Physical exam including clinical assessments of facial hair and acne were monitored.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible women must:
- •Be 40-70 years old and in generally good health
- •Be post-menopausal with no spontaneous periods for 1 year
- •Be receiving a stable dose of hormone replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
- •Be, in her own judgment, in a stable, monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry
- •Meet the criteria for having hypoactive sexual desire disorder
排除标准
- •Eligible women must not:
- •Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
- •Be experiencing any chronic or acute life stress relating to any major life change
- •Be experiencing depression and/or receiving medication for such illness or disorder
- •Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
- •Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
- •Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
- •Have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years
- •Have abnormal laboratory test results upon initial screening for this study
- •Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days
研究组 & 干预措施
1
Placebo patch
干预措施: Placebo patch (Drug)
2
testosterone patch (300 mcg/day) patch changed 2 times/week, for one year
干预措施: Testosterone Transdermal System (Drug)
结局指标
主要结局
To assess the efficacy of the transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL).
时间窗: 12 months
次要结局
- To assess the efficacy measured by the change from baseline in sexual desire using personal distress as measured by the Personal Distress Scale (PDS) score; the other 6 domains of the Profile of Female Sexual function, and the other 8 SAL endpoints.(12 months)