Study to Evaluate Efficacy and Safety of Transdermal Testosterone and Safety for an Open-label Period in Women With Hypoactive Sexual Desire Disorder on Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 562
- 试验地点
- 1
- 主要终点
- To assess the efficacy of testosterone 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 surgically menopausal women who are taking estrogen therapy.
详细描述
Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 52-week, multicenter, multinational study that included a 24-week, double-blind (DB), parallel-group, placebo-controlled period followed by a 28-week open-label (OL) period. Patients were stratified based on their use of oral or transdermal ET and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen throughout the study. Upon completion of the DB period, patients receiving placebo were switched to TTS, while the active cohort remained on active treatment. All patients were then followed for an additional 28 weeks for safety. Patients who completed the first 52 weeks of the study were given the opportunity to participate in an open label extension (Years 2, 3 , and 4), which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, coagulation testing, and hematology. 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
- 20 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 20-70 years old and in generally good health
- •Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening
- •Be receiving a stable dose of estrogen 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 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 P&GP study 1999068 or 1999092
- •Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.
研究组 & 干预措施
Placebo
Placebo patch
干预措施: Placebo (Drug)
Testosterone Patch
干预措施: Testosterone Transdermal System (Drug)
结局指标
主要结局
To assess the efficacy of testosterone 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: 24 weeks
次要结局
- To assess the efficacy measured by the change from baseline in sexual desire; personal distress as measured by the Personal Distress Scale score; the other 6 domains of the profile of Female Sexual Function; and the other 8 SAL endpoints.(24 weeks)