Health risks and treatment of anabolic-androgenic steroid (AAS) induced hypogonadism among men – a pilot study exploring off-label use of clomiphene citrate to reduce symptoms of androgen deficiency after AAS-cessation - Clomiphene citrate to Treat Anabolic-Androgenic Steroid induced Hypogonadism among men

Oslo University Hospital0 个研究点目标入组 1 人开始时间: 2021年8月4日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Oslo University Hospital