NL-OMON43503已完成不适用
A Phase I, double-blind, randomised, placebo-controlled, multiple dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of two dosages of estetrol in healthy men - PR3107 (CS0256)
Pantarhei Oncology0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Healthy male, age between 40 and 70 years (both inclusive);
- •* Body mass index between *18.5 and *30.0 kg/m2;
- •* Normal prostate-specific antigen (PSA) value (< 3.0 ng/mL);
排除标准
- •* Any clinically significant abnormality following review of medical history, laboratory results,
- •physical examination and ECG at screening;
- •* Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of
- •any of the study drugs;
- •* Previous use of steroids within:
- •o 8 weeks for oral preparations
- •o 4 weeks for transdermal preparations
- •o Any time for injections;
- •* No contraindications for steroids or estetrol use;
- •* Prostate hyperplasia or micturition problems that suggest the presence of prostate hyperplasia (micturition problems are defined as a score of >7 based on the International Prostate Symptom Score (I-PSS) questionnaire);
- •* Presence of an active acute or chronic infection, including syphilis, HIV or viral hepatitis B and/or
- •C (or previously treated);
研究者
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