PHASE III, ACTIVE-CONTROLLED, SAFETY AND EFFICACY TRIAL OF ORAL TESTOSTERONE UNDECANOATE (TU) IN HYPOGONADAL MEN.

CLARUS THERAPEUTICS, INC.0 个研究点目标入组 300 人开始时间: 2011年8月12日最近更新: 2013年8月26日

研究概览

暂无简介。

•(1) Male, 18 to 75 years of age, inclusive, with hypogonadism as defined by a total serum T of =300 ng/dL, collected in the morning before 10:00
•AM on two occasions within one week (on separate days).
•(2) With adequate venous access in their left or right arm to allow
•collection of a number of blood samples via a venous cannula.
•(3) Must be naïve to androgen-replacement therapy (or washout
•required), be willing to temporarily cease current T treatment, or
•currently not be taking T treatment in order to participate in the study.
•(4) If on replacement therapy for hypopituitarism or multiple endocrine deficiencies, the subject must be on stable doses of thyroid hormone and adrenal replacement hormones for at least 14 days prior to enrollment.
•(5) Have voluntarily given written informed consent to participate in this study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•(1) Oral, topical (e.g., gel or patch) or buccal T therapy within the previous one week, or intramuscular T injection of short acting duration within the previous 4 weeks.
•(2) Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness.
•(3) Subjects with recent (within 3 months) history of stroke, not including transient ischemic attack (TIA).
•Further exclusion criteria: protocol, section 7.3.

发起方