Anabolic androgenic steroid induced hypogonadism among men
Conditions
Interventions
Trade Name: Clomifen ferring
Clomiphene citrate
Product Name: Clomifen ferring
Product Code: 229903
Pharmaceutical Form: Tablet
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim is to explore whether off-label use of clomiphene citrate for 16 weeks is safe, and more effective than following AAS-cessation without intervention on reduction of symptoms of androgen deficiency hypogonadism and other health measures related to AAS use.;Secondary Objective: The secondary aims are to detect health risks during ongoing AAS use in the intervention group and assess whether these physical (e.g. liver, vascular, endocrine and metabolic status, body and fat tissue composition, testicular volume and sperm quality), and mental health risks (e.g. depression, anxiety, AAS dependence, body dysmorphia, aggression) for the intervention group are changed 12 months after cessation.;Primary end point(s): Primary end points: Side effects related to clomiphene citrate Change in self reported symptoms of hypogonadism at baseline and at 2,4,6,8,10,12,14,16,26 weeks. •Fatigue •Depression •Anxiety •Sexual dysfunction Change in symptoms related to AAS use at baseline and follow up points •Aggression •Body dysmorphia •Quality of life •Sleep Pain ;Timepoint(s) of evaluation of this end point: Inclusion, 4 weeks, 8 weeks, 12 weeks, 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: Change in measures of physical health from baseline to follow-up: Liver function blood test Endocrine status-blood tests Vascular status Metabolic status Body composition Fat tissue Testicle volume and sperm quality Change in measures of mental health risks from baseline to follow-up: Depression and anxiety AAS dependence Body image Aggression AAS use Adherence to SUD treatment ;Timepoint(s) of evaluation of this end point: Inclusion, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 26 weeks, 52 weeks | — |
Countries
Norway
Contacts
Public ContactAAS Research Group/Steroid project
Oslo University Hospital
Outcome results
None listed