NCT03242590已完成3 期
Validation of Dosing Regimen 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
- 95
- 主要终点
- Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
研究概览
简要总结
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
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
- •Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy.
- •Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
- •Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.
排除标准
- •History of significant sensitivity or allergy to androgens, or product excipients.
- •Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
- •Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).
- •Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
- •Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis
- •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 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 untreated and severe obstructive sleep apnea.
- •History of long QT syndrome (QTc > 450) or unexplained sudden death in a first degree relative (parent, sibling, or child).
研究组 & 干预措施
Oral testosterone undecanoate, LPCN 1021
Experimental
Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.
干预措施: LPCN 1021 (Drug)
结局指标
主要结局
Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
时间窗: Following 24 days of treatment
The primary efficacy endpoint and analysis for this study was the percentage of LPCN 1021 treated subjects who had achieved a 24-hour average serum T concentration within the normal range of 300 to 1080 ng/dL at Visit 4, (Day 24 ± 4 days).
次要结局
未报告次要终点
研究者
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