E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anabolic androgenic steroid induced hypogonadism among men |
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E.1.1.1 | Medical condition in easily understood language |
Long-term anabolic steroid use has negative feedback on the testosterone production resulting in absent/low level of testosterone and symptoms such as depression, fatigue and sexual dysfunction. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Inclusion, 4 weeks, 8 weeks, 12 weeks, 16 weeks |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Inclusion, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 26 weeks, 52 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
The study has an open, single center - single group - case - comparison design |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |