Energy, Sexual Desire and Body PropoRtions wIth AndroGel®, Testosterone 1% Gel Therapy (ESPRIT) in Hypogonadal Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 1,053
- 试验地点
- 331
- 主要终点
- Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score
研究概览
简要总结
Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.
详细描述
The objective of this study was to evaluate the efficacy and safety of AndroGel (testosterone gel) 1% following administration in community dwelling men with hypogonadism. The percent change from baseline to Month 6 in aging male symptom (AMS) assessment was the primary endpoint. Secondary endpoints were changes from baseline to Month 6 in International Index of Erectile Dysfunction (IIEF), Multidimensional Fatigue Inventory (MFI), and body mass index (BMI) assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 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
AndroGel (testosterone gel )1%
AndroGel is topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose.
干预措施: AndroGel (testosterone gel) 1% (Drug)
结局指标
主要结局
Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score
时间窗: Baseline to Month 6
The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the \[(AMS value at Month 6 - AMS value at baseline)/baseline value\] x 100.
次要结局
- Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score(Baseline to Month 6)
- Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score(Baseline to Month 6)
- Percent Change From Baseline to Month 6 in Body Mass Index (BMI)(Baseline to Month 6)