The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- Overall mood
研究概览
简要总结
RATIONALE: The hormone testosterone may improve the libido (sex drive) in women. It is not yet known whether testosterone is effective in improving libido in female cancer survivors.
PURPOSE: This randomized phase III trial is studying how well low-dose testosterone works to improve libido in postmenopausal cancer survivors.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of low-dose testosterone, in terms of average intra-patient change in libido, in postmenopausal female cancer survivors with a decreased libido.
Secondary
- Determine the toxic effects of this drug in these patients.
- Determine the levels of estrogen and testosterone and SGOT in patients reporting a decreased libido before and after treatment with this drug.
- Determine whether increasing libido significantly positively affects pleasure from sexual activity in patients treated with this drug.
- Determine the effect of this drug on vitality, general quality of life, and overall mood in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
testosterone
Patients receive topical testosterone once daily for 4 weeks. After 4 weeks, patients cross over to the other treatment arm.
Changes in sexual functioning, mood states, and medical outcome vitality are assessed at baseline and then at the end of weeks 4 and 8.
Patients who continue or restart testosterone cream after the 8-week study period are followed at 6 months.
干预措施: therapeutic testosterone (Drug)
placebo
Patients receive a topical placebo once daily for 4 weeks. After 4 weeks, patients cross over to the other treatment arm.
Changes in sexual functioning, mood states, and medical outcome vitality are assessed at baseline and then at the end of weeks 4 and 8.
Patients who continue or restart testosterone cream after the 8-week study period are followed at 6 months.
干预措施: placebo (Other)
结局指标
主要结局
Overall mood
时间窗: Up to 6 months
次要结局
- overall vitality(Up to 6 months)
- quality of life(Up to 6 months)