A Phase IV, Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of 16 Weeks Treatment With Androderm® in Hypogonadal Men
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 168
- 试验地点
- 40
- 主要终点
- Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
研究概览
简要总结
This study will evaluate the effect of a once daily Androderm® dose on Blood Pressure (BP) in adult hypogonadal men as measured by 24-hour ABPM.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and dehydroepiandrosterone (DHEA), including investigational products that may affect the reproductive hormonal system or has not been treated with these compounds in the past 6 months
- •Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
- •Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
- •Body mass index (BMI) < 35 kilograms per metre square (kg/m^2)
排除标准
- •Uncontrolled systemic disease or clinically significant disease, in particular, liver, kidney or heart disease, including hypertension, congestive heart failure, coronary heart disease, chronic atrial fibrillation, sleep apnea or psychiatric illness, that in the investigator's opinion, would put the participant at an unacceptable risk with exposure to Androderm®
- •History of prostate (current or in the past) or breast cancer
- •Had a recent (within 2 years) history of stroke, transient ischemic attack, acute coronary event, venous thrombotic, or thromboembolic event
- •History of alcohol or other substance abuse within the previous 2 years
- •Known allergy or sensitivity to the study intervention or its components or other testosterone replacement medications
- •Participant who works night shifts or who will need to perform strenuous manual labor while wearing the ABPM monitor
研究组 & 干预措施
Androderm® 4 mg
Participants received Androderm® 4 mg, transdermal dose, once daily (QD) for up to 16 weeks. At Day 14, if serum concentration was less than 400 nanograms per deciliter (ng/dL), the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
干预措施: Androderm® (Drug)
结局指标
主要结局
Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
时间窗: Baseline and Week 16
SBP was collected by 24-hour ambulatory blood pressure monitoring (ABPM) device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged.
次要结局
- Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16(Baseline and Week 16)
- Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16(Baseline and Week 16)
- Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16(Baseline and Week 16)
- Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16(Baseline and Week 16)