None listed
Conditions
Brief summary
Investigating whether a short course of treatment with hCG will speed up the recovery of the suppressed reproductive system in men who have been using androgens (“anabolic steroids”) without medical reason or prescription. In men who have previously used androgens but have stopped within the last month or are planning to stop soon. Participants will be randomly allocated to receive either the active drug or an identical placebo.
Interventions
Subcutaneous injections of 250 µg recombinant human chorionic gonadotrophin (HCG) (Ovidrel) once a week for 4 weeks. Administered in the department by a registered nurse involved in the study.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Male androgen abusers with characteristic androgen deficiency-type withdrawal symptoms (lethargy, easy fatigue, sexual dysfunction, male infertility) or likelihood of them developing History of androgen abuse defined as having had at least two characteristic periods of using non-prescribed androgens within a year with the most recent ending more than 4 weeks prior to visit 2 (study week 0). Intend to stop using any exogenous androgens during the study Must have ceased androgen intake for at least one month
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 inability to provide consent such as due to major psychiatric disease or psychological condition that, in the investigator’s opinion, may limit understanding and compliance with the requirement of this study Volunteer considered unlikely, in the investigator’s opinion, to complete study requirements
Outcome results
None listed