Randomized Placebo-Controlled Clinical Trials on the Effect of Letrozole on Recovery from Non-Prescribed Androgen Use

Phase 4

Not yet recruiting

• Conditions: Androgen Abuse; Metabolic and Endocrine - Other endocrine disorders

• Registration Number: ACTRN12621001751864
• Lead Sponsor: HMRC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-21
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Male
• Target Recruitment: 45

Inclusion Criteria

•Men over 18 years old in otherwise good health
•Characteristic androgen deficiency-type withdrawal symptoms (lethargy, easy fatigue, sexual dysfunction, male infertility)
•History of androgen abuse defined as having had at least two characteristic periods of using of non-prescribed androgens within a year with the most recent ending within the previous 4 weeks
•Intend to stop using any exogenous androgens by start of, and during, study

Exclusion Criteria

•History of any chronic disease or condition requiring regular medical management
•History of hypothalamo-pituitary or testicular dysfunction unrelated to androgen abuse
•Allergic or other severe adverse reaction to hCG injections or letrozole and their ingredients
•History of major psychiatric disease or psychological condition that, in the investigator’s opinion, may limit understanding and compliance with the requirement of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified