24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 2
- 主要终点
- To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters.
研究概览
简要总结
The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.
详细描述
This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.
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
- •Women will be screened for study participation according to the following inclusion criteria at Week -
- •Eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal HRT and in a stable monogamous sexual relationship with low sexual desire causing distress.
排除标准
- •Women will be screened for study participation according to the following exclusion criteria at Week -4 or as specified. Eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.
研究组 & 干预措施
1
300mcg/day testosterone
干预措施: Testosterone (Drug)
2
Placebo arm
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters.
时间窗: Assessment at 12 and 24 weeks
次要结局
- To assess the efficacy of the TTS as measured by the following parameters: changes in sexual desire, personal distress, and other domains of PFSF and SAL questionnaires.(Assessment at 12 and 24 weeks)