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
NCT05205837 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2024-02-15
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.
Conditions
- Hypogonadism
- Hypogonadism, Male
- Hypogonadotropic Hypogonadism
Interventions
- DRUG
-
Letrozole 2.5mg, hCG
Drug -Treatment Intramuscular injektion - Treatment
- DRUG
-
Drug - Placebo Intramuscular injektion - placebo
Sponsors & Collaborators
-
Rigshospitalet, Denmark
lead OTHER
Principal Investigators
-
Caroline Michaela Kistorp, professor, MD · Rigshospitalet, Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-24
- Primary Completion
- 2023-08-15
- Completion
- 2023-08-15
Countries
- Denmark
Study Locations
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