ot applicable

Phase 1

• Conditions: Hypogonadal men; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-001638-41-GB
• Lead Sponsor: CLARUS THERAPEUTICS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-01
• Study Completion: 2013-04-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 321

Inclusion Criteria

(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

Exclusion Criteria

(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 page 29.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified