A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 20
- 主要终点
- Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
研究概览
简要总结
Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
详细描述
Safety assessments, including laboratory assessments, adverse events and injection site assessments, will be conducted for all patients at scheduled intervals during the Treatment Titration Period.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult men ≥18 and ≤75 years of age with a documented history of hypogonadism
- •Total testosterone levels < 300 ng/dL at two qualification visits
- •Patients in good general health
排除标准
- •Allergy to sesame or testosterone products
- •BMI ≥ 40 kg/m2
- •Hematocrit ≥ 52%
- •History or current evidence of breast or prostate cancer
- •Elevated prostate-specific antigen (PSA) for age.
- •Abnormal digital rectal examination (DRE)
- •Unstable psychiatric illnesses
- •Obstructive uropathy of prostatic origin
- •Poorly controlled diabetes
- •Congestive heart failure
- •Within 6 months of screening, myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
- •History or current treatment of thromboembolic disease.
- •Use of adrenocorticotropic hormone (ACTH) or oral/depot corticosteroids within 6 weeks of screening.
- •History of severe, untreated sleep apnea
- •Subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
- •Positive serology for HIV, hepatitis B or hepatitis C
- •Current evidence of drug or alcohol abuse.
- •Skin conditions in injection site that could confound injection site assessments.
- •Administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer).
- •Use of estrogen, gonadotropin-releasing hormone (GnRH) or growth hormone within 12 months of screening.
- •Use of other androgens (DHEA), anabolic steroids, other sex hormones) or other substances/supplements know to affect the pharmacokinetics (PK) of testosterone enanthate
- •Considered or scheduled surgical or dental procedures associated with blood loss ≥500 mL during study.
- •Donation of plasma or blood within 56 days of screening or history of donation of > 50 mL of blood or plasma within 3 months of screening.
- •Donation of plasma or blood during study
研究组 & 干预措施
Testosterone enanthate auto-injector
Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
干预措施: Testosterone enanthate auto-injector (Combination Product)
结局指标
主要结局
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
时间窗: 26 weeks
Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population. Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)
次要结局
未报告次要终点