Randomized Placebo-Controlled Clinical Trials on the Effect of human chorionic gonadotrophin (hCG) on Recovery from Non-Prescribed Androgen Use

Phase 4

Not yet recruiting

Conditions: Androgen abuse
Metabolic and Endocrine - Other endocrine disorders

Registration Number: ACTRN12621001753842

Lead Sponsor: Sydney Local Health District (SLHD)

Brief Summary: Not available

Detailed Description: Not available

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 nonprescribed 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

Primary Outcome Measures

Name	Time	Method
Composite measure of recovery based on serum LH and FSH[4 weeks AFTER treatment finishes]

Secondary Outcome Measures

Name	Time	Method
Time course of Quality of life (SF12) questionnaires.[at 4 and 8 weeks after post treatment];Time course of Quality of life (PDQ) questionnaires [at 4 and 8 weeks post treatment];Time course of Quality of life and psychosexual function questionnaires (IIEF)[at 4 and 8 weeks post treatment];Time course of changes in mood (PHQ-9)[at 4 and 8 weeks post treatment];Time course of onset of anxiety and depression, if any, using HADS questionnaires<br>[at 4 and 8 weeks post treatment]