A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men
概览
- 阶段
- 3 期
- 干预措施
- Placebo Solution
- 疾病 / 适应症
- Hypogonadism
- 发起方
- Eli Lilly and Company
- 入组人数
- 715
- 试验地点
- 1
- 主要终点
- Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12
- 状态
- 已完成
- 最后更新
- 10年前
概览
简要总结
The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.
研究者
入排标准
入选标准
- •Total testosterone level \<300 nanogram per deciliter (ng/dL) \[10.4 nanomole per Liter (nmol/L)\] at each of 2 screening visits
- •At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive
- •Prostate Specific Antigen (PSA) \<4 nanogram per milliliter (ng/ml) at screening
排除标准
- •Sexual partner who is or becomes pregnant at any time during the study
- •Use of long-acting intramuscular (IM) testosterone undecanoate or testosterone pellets in the 6-month period prior to screening
- •Body Mass Index (BMI) \>37 kilogram per square meter (kg/m\^2) at screening
- •Severe lower urinary tract symptoms and/or significant prostate enlargement
- •Prolactin lab test result of \>30 ng/mL at screening
- •Hemoglobin A1c (HbA1c) \>11% at screening
- •Hematocrit ≥50% (\>54% at elevated altitude) at screening
- •Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone
- •Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy
- •Currently receiving treatment with cancer chemotherapy or antiandrogens
研究组 & 干预措施
Placebo Solution
Placebo Solution applied topically once daily for 12 weeks.
干预措施: Placebo Solution
Testosterone Solution
Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks.
干预措施: Testosterone Solution
结局指标
主要结局
Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12
时间窗: Week 12
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
次要结局
- Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores(Baseline, Week 12)
- Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores(Baseline, Week 12)
- Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)(Double Blind Baseline, Week 12, Open Label Baseline, Week 36)