None listed
Conditions
Brief summary
AIMS OF THIS STUDY To test model PCT-style regimen of hCG , framed in the most plausible endocrinological context, to evaluate their efficacy in accelerating the recovery of male reproductive function of abstinent androgen abusers. This randomized double-blind placebo-controlled clinical trial is designed to test the efficacy and safety of a pharmacological treatment as part of a future rehabilitation program for androgen abusers. To the best of our knowledge, no similar study has been undertaken or reported elsewhere. OBJECTIVES To investigate the efficacy of weekly hCG treatment over 4 weeks to accelerate recovery of the male reproductive system of abstinent androgen abusers at 4 and 8 weeks after cessation of trial drug treatment. STUDY POPULATION Androgen abusers who are planning to stop or have recently ceased androgen abuse will be recruited through local advertising, social media postings and word of mouth. STUDY DESIGN Randomized, double-blind, placebo-controlled, parallel group study with 4 weeks of drug (active or placebo) treatment. The primary endpoint is the extent of recovery of the male reproductive system as indicated by a composite measure of serum LH and FSH at 4 and 8 weeks after cessation of study drug treatment.
Interventions
A single subcutaneous injection of:
hCG in a dose of 5000 IU or saline placebo once a week for 4 weeks. The injection will be administered by study staff at the study site and documented as given or otherwise.
Sponsors
Sydney Local Health District (SLHD)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Healthy volunteers
No
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
Outcome results
None listed