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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Terminated PHASE4 INTERVENTIONAL NCT05205837

A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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, adherence to cessation of AAS use, fertility, cardiac function and quality of life.

Detailed Description

A randomized, double-blinded, clinical, placebo-controlled trial enrolling 60 male illicit AAS users with documented AAS-induced hypogonadism after a period \> 12 weeks of AAS cessation or a negative urine AAS doping test. Participants will be randomized to two study groups; 24 weeks of treatment with either tablet letrozole (femar®) initial dose of 2.5 mg each day versus tablet placebo. After an initial treatment period of four weeks, intramuscular injections with either hCG, initial dose 1500 IE twice weekly (letrozole group) or isotonic saline twice weekly (placebo group) will be added to therapy if plasma total testosterone level has not increased to target plasma level. Following 24 weeks of therapy, all participants will be observed for another 26 weeks without therapy. The study will have one trial center of recruitment: Department of Endocrinology, Rigshospitalet. Following participation in the study, all participants will be offered referral to an endocrine outpatient clinic if they still display clinical and biochemical signs of male hypogonadism. A healthy group of 30 young lean eugonadal men, who have never used AAS, will be enrolled as control participants and undergo a screening visit and one visit including same procedures as the screening and randomization visits.

Interventions

Name: Letrozole 2.5mg, hCG
Type: DRUG
Description: Drug -Treatment Intramuscular injektion - Treatment
Name: Placebo
Type: DRUG
Description: Drug - Placebo Intramuscular injektion - placebo

Primary Outcomes

Measure: Change in plasma total testosterone concentration after 24 weeks from baseline
TimeFrame: 24 weeks
Description:

Trial Information

NCT ID

NCT05205837

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Rigshospitalet, Denmark

Last Updated

December 15, 2025