A randomized trial on the effect of medical therapy in men with side-effects related to illicit use of anabolic steroids

Phase 1

• Conditions: Male hypogonadism related to illicit use of anabolic androgenic steroids; MedDRA version: 20.0Level: PTClassification code 10058359Term: HypogonadismSystem Organ Class: 10014698 - Endocrine disorders; MedDRA version: 21.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-002612-52-DK
• Lead Sponsor: Department of Endocrinology, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-06
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

•Male sex
•18 – 50 years of age
•Hypogonadism following observational period of a minimum of 12 weeks since AAS discontinuation or a urine sample negative for AAS analyses at screening visit: plasma total testosterone = 10 nmol/L AND featuring at least one symptom of male hypogonadism using IIEF in terms of erectile function (IIEF: Q1 – Q5 + Q15; total score < 26) and/or sexual desire (IIEF: Q11 + Q12; total < 7) (1) and/or ADAM questionnaire (YES to three questions other than question 1 and 7) and/or regular use of medical treatment for erectile dysfunction.

• Motivation for permanent AAS cessation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Established cardiovascular disease
•Established diabetes of any kind
•Congenital hypogonadal conditions (cryptorchidism, Klinefelter’s disease, Kallmann’s disease etc.)
•Previous established hypogonadal conditions due to other causes than illicit use of AAS
•Current or previous treatment with testosterone on other indication than AAS-induced male hypogonadism
•Abnormal puberty development (small testes, late or absent pubic hairing, late or absent deepening of voice, etc.)
•Current or previous pituitary diseases
•Current or former testicular cancer
•Other cancers unless complete remission = 5 year
•Other concomitant disease or treatment which according to the investigators’ assessment makes the patient unsuitable to participate in the study
•Simultaneous participation in another clinical study
•Unable to follow treatment instructions in terms of study medication instructions
•Ongoing criminal behavior in terms of violence or illicit distribution of drugs
•Currently or in the foreseeable future included in anti-doping programs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The overall objective of this randomized trial is to investigate the effects of treatment of AAS-induced male hypogonadism with combined therapy of letrozole and hCG compared with placebo on reproductive hormone levels ;Secondary Objective: The secondary objectives are: adherence to cessation of AAS use, fertility, cardiac function and quality of life.;Primary end point(s): Change in plasma total testosterone concentration after 24 weeks from baseline ;Timepoint(s) of evaluation of this end point: after 24 weeks