24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 45
- 主要终点
- Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)
研究概览
简要总结
Hypogonadism is an endocrine disorder characterized by absent or deficient testosterone levels along with signs and symptoms of androgen deficiency, including delayed development or regression of sexual characteristics, impaired sexual function and sense of well-being, depressed mood, decreased muscle strength associated with loss of muscle mass and reduced bone mineral density. AndroGel 1.62% has demonstrated its ability to increase total testosterone levels in the blood by absorption of testosterone through the skin when applied topically. This study evaluated the effect of AndroGel 1.62% on systolic blood pressure using ambulatory blood pressure monitoring in hypogonadal men who used testosterone replacement therapy.
AndroGel 1.62% is a drug used for the treatment of hypogonadism, which is associated with low or no testosterone. This was an open-label study which means that both the study doctor and study participants knew what drug and what dose is being used. All participants in this study were in the same group, called a treatment arm. Adult male participants with hypogonadism were enrolled and received AndroGel 1.62%. This was a multi-center study with 190 participants enrolled (initially planned) in approximately 45 sites in the United States to yield 171 subjects in the per protocol (PP) population. A blinded sample size re-estimation (BSSR) was performed when around 70% of the planned subjects in the PP population had completed the end of treatment visit. Sample size was increased at BSSR and 246 participants were actually enrolled.
Participants received daily topical gel doses of AndroGel 1.62% for approximately 16 weeks.
There may have been a higher burden for participants in this study compared to standard of care. Participants attended 8 study visits during the course of the study at a hospital or clinic and received 2 study phone calls. The effect of the treatment was checked by medical assessments, blood tests (including pharmacokinetic sampling), and 24-hour blood pressure monitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of hypogonadism with the presence of at least one of the following symptoms that may be related to low testosterone values and is/are consistent with hypogonadism:
- •Decreased sexual desire or libido
- •Decreased spontaneous erections (e.g. morning erections)
- •Decreased energy or fatigue/feeling tired
- •Low mood or depressed mood
- •Loss of body (axillary and pubic) hair or reduced shaving
- •Hot flashes AND
- •Confirmed by 2 serum testosterone levels < 300 ng/dL by blood samples drawn at least 48 hours apart. These samples should be obtained between 5 am and 11 am local time.
- •Blood pressure >100/60 mmHg and <140/90 mmHg
排除标准
- •Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known thrombophilia
- •Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated sleep apnea or severe chronic obstructive pulmonary disease
- •Prostate or breast cancer
- •Any active malignancy
- •Clinically significant medical conditions or any other reason that the investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug
- •Work night shifts or is otherwise required to perform strenuous manual labor while wearing the Ambulatory Blood Pressure Monitor (ABPM).
研究组 & 干预措施
AndroGel 1.62%
AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study, for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.
干预措施: AndroGel 1.62% (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)
时间窗: Baseline, Week 16
Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day).
次要结局
未报告次要终点