NCT00969163已完成1 期
A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- serum free testosterone concentrations following multiple doses of AndroGel
研究概览
简要总结
Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 3 years postmenopausal
- •Subject is in good general health
- •Subject is willing to avoid excess alcohol or strenuous physical activity during the study
排除标准
- •Subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks
- •Subject is a regular user of any illicit drugs
- •Subject drinks excessive amounts of coffee, tea or cola
- •Subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months
- •Subject has a history of cancer
- •Subject has acne
研究组 & 干预措施
1
Experimental
2.5 mg testosterone gel
干预措施: testosterone gel (Drug)
2
Experimental
300 ug testosterone gel
干预措施: testosterone gel (Drug)
结局指标
主要结局
serum free testosterone concentrations following multiple doses of AndroGel
时间窗: 6 weeks
次要结局
- mean percent change from baseline in sebum excretion(6 weeks)
研究者
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