The Quality of Life Outcomes and the Pharmacokinetic and Pharmacodynamic Sequelae of Testosterone Undecanoate Injections compared with Testosterone Implants for Androgen Replacement Therapy in men with Classical Male Hypogonadism

Phase 4

Recruiting

• Conditions: Male hypogonadism; Metabolic and Endocrine - Other metabolic and endocrine disorders

• Registration Number: ACTRN12606000315516
• Lead Sponsor: Schering Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Established androgen deficiency requiring testosterone replacement therapy. Otherwise medically stable. Able to understand and comply with the study design.

Exclusion Criteria

Known contraindications to androgen therapy (eg. prostate cancer). Known allergy to castor oil vehicle of injections. Known significant systemic or mental illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Individual and disease specific quality of life variables (reproductive hormones, subjective symptoms of androgen deficiency).[These will be measured at baseline, +2weeks, +4 weeks, +6 weeks, +12 weeks, +18 weeks and +30 weeks for the TU arm of the study and baseline, +2 weeks, +4 weeks, +12 weeks and at approximately 20 weeks for the TI arm of the study.]

Secondary Outcome Measures

Name	Time	Method
Androgen sensitive clinical measures (body composition, muscle strength, hemoglobin, sexual activity). [These will be measured at baseline, + 12 weeks and at + 30 weeks for the TU arm and approximately 20 weeks for the TI arm.]