An 8-Week Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 16
- 主要终点
- Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score
研究概览
简要总结
To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.
详细描述
This phase 2 study is a double-blind, placebo controlled, parallel arm study with a 4 week run-in and an 8-week treatment period. It will assess the safety and tolerability of fispemifene, and the effects of treatment on the sexual side effects seen in this patient population using PRO endpoints.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of secondary hypogonadism
- •Mild to moderate erectile dysfunction
- •Ability to read, understand and complete diaries and questionnaires
- •Ability to safely make sexual attempts during the course of the study
排除标准
- •Primary hypogonadism
- •Hypogonadism as a result of surgery, trauma, tumors or radiation of the hypothalamus or pituitary
- •History or current diagnosis of breast cancer, prostate cancer and/or PSA level above ≥3.5 ng/mL
- •Poorly controlled blood pressure, type 2 diabetes, thyroid disease; sleep apnea
- •Elevated prolactin level
- •Hemoglobin >17 g/dL or Hematocrit >50%
- •Use of transdermal or oral testosterone within 4 weeks, intramuscular testosterone therapy within 6 weeks, and testosterone pellets within 6 months prior to Screening and at any time throughout the study
- •Use of another SERM or past participation in a trial with Fispemifene
- •Use of medications known to alter the HPG axis
- •Clinically significant findings on physical exam, screening labs, or other findings which would prevent safe participation in the study
- •Participation in another clinical study in the last 30 days
研究组 & 干预措施
Fispemifene 450 mg
Fispemifene capsules will be taken orally each morning immediately after eating a meal
干预措施: fispemifene (Drug)
Placebo
Placebo capsules will be taken orally each morning immediately after eating a meal
干预措施: Placebo (Other)
结局指标
主要结局
Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score
时间窗: 8 weeks
Change in the IIEF-EF (International Index of Erectile Function - erectile function domain) score from Randomization to Week 8
次要结局
未报告次要终点