Health risks and treatment of anabolic-androgenic steroid (AAS) dependence – a pilot study exploring endocrine therapy to reduce withdrawal symptoms upon AAS-cessatio

Phase 1

• Conditions: Anabolic androgenic steroid induced hypogonadism among men; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-005938-15-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-04
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

Gender: male
6 months or more of continuous AAS use,
Disease characteristics: ASIH as measured by LH and FSH below lower limit for
normal range and testosteron above upper limit for normal range.
Still using AAS or having ended AAS use less than 4 weeks prior to inclusion,
A wish to end AAS use permanently
Fulfilling of the criteria for AAS dependence (3 of 9 criteria)
Being referred or being enrolled in SUD treatment
Liver enzymes alanine transaminase (ALT) and aspartate transaminase (AST) =3 x upper limit of normal range (ULN) for men above 18 years. Normal range AST (15-45U/L), ALT (10-70U/L).
Serum-testosterone must be below 25 nmol/L at intervention start.

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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Current or previous arrhythmia, ischemic heart conditions or heart failure
Tromboembolic disease – previous DVT, pulmonary embolism,
Hemoglobin above 18.0 gdl.
Severe mental disorder including severe depression with or without psychotic symptoms, psychosis and bipolar disorder
Non-prescribed use of hormones
Current recreational drug use disorder involving ongoing illicit substance use.
Hypersensitivity to clomiphene citrate, hyperprolactinemia and
uncontrolled thyroid- og adrenal dysfunction.

Study & Design

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