NCT02081300已完成3 期
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 315
- 主要终点
- Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
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
- 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
- •Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
- •Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples
排除标准
- •A subject will not be eligible for study participation if he meets any of the following criteria.
- •History of significant sensitivity or allergy to androgens, castor oil or product excipients.
- •Clinically significant findings in the prestudy examinations.
- •Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score > 19 points.
- •Body mass index (BMI) ≥ 38 kg/m
- •Clinically significant abnormal laboratory values
- •Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab).
- •History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
- •History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- •History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
- •History of stroke or myocardial infarction within the past 5 years.
- •History of, or current or suspected, prostate or breast cancer.
- •History of diagnosed, severe, untreated, obstructive sleep apnea.
- •History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
- •History of long QT syndrome or unexplained sudden death in a first degree relative (parent, sibling, or child).
- •Concurrent treatment with medications which may impact the absorption, distribution, metabolism or excretion of testosterone undecanoate (TU) or place the subject at risk for treatment with testosterone.
- •Subject has a partner who is currently pregnant or planning pregnancy during the course of the clinical trial.
研究组 & 干预措施
Oral testosterone undecanoate, LPCN 1021
Experimental
Oral testosterone undecanoate: Initial dose: 225 mg TU BID. Dose titrated up to 300 mg TU BID or down to 150 mg TU BID based on serum T at Week 3 and 7.
干预措施: Oral testosterone undecanoate, LPCN 1021 (Drug)
Topical testosterone gel 1.62 %
Other
Topical testosterone gel 1.62%: Initial dose: 40.5 mg T once daily. Dose titrated down to 20.25 mg or up to 81 mg based on serum T on Days 14 and 28
干预措施: Topical testosterone gel 1.62 % (Drug)
结局指标
主要结局
Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.
时间窗: Following 13 weeks of treatment
次要结局
- Percentage of LPCN 1021-treated subjects with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng/dL; (b) between 1800 and 2500 ng/dL, and (c) greater than 2500 ng/dL(Following 13 weeks of treatment)
- Change from baseline in patient reported outcomes for LPCN 1021 (i.e., International Prostate Symptom Score [I-PSS], Psychosexual Daily Questionnaire [PDQ], Short Form-36 Questionnaire [SF-36])(52 weeks)
- Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA)(52 weeks)
- Number of subjects with adverse events during 52 weeks of treatment(52 weeks)
研究者
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