A Research Study of Injections of Testosterone in an Oil Vehicle for men with Androgen Deficiency: Reandron (Testosterone Undecanoate) will be administered subcutaneously and intramuscularly.
Phase 4
Completed
- Conditions
- Male HypogonadismMetabolic and Endocrine - Other metabolic disorders
- Registration Number
- ACTRN12613000101785
- Lead Sponsor
- Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 11
Inclusion Criteria
*Already receiving regular testosterone treatment.
*Written, informed consent & willing to comply with study requirements
Exclusion Criteria
*Contraindication to testosterone
*History of major psychiatric disease or psychological condition that may limit understanding and compliance with study requirements
*Regular medications that interfere with absorption, metabolism or action of testosterone which may require dosage change during the study
*Taking medications for antiplatelet or anticoagulant therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time profile of serum testosterone concentrations.[12 weeks post each testosterone injection]
- Secondary Outcome Measures
Name Time Method Time profile of serum DHT, estradiol, LH and FSH concentrations[12 weeks post injection];Patient preference will be measured by self administered Likert scale.[At the completion of the study (24 weeks).];Patient acceptability will be measured by self administered Likert scale. [Immediately after both SC and IM injections and at the completion of the study (24 weeks).];Patient pain will be measured by self administered Likert scale [Immediately after the injections (SC and IM) and 24 hours post injections.]