A randomized trial on the effect of medical therapy in men with side-effects related to illicit use of anabolic steroids

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 on plasma reproductive hormones, fertility, withdrawal symptoms and myocardial function - The LUCAS trial - LUCAS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002612-52-DK

Enrollment

Registered

2020-11-06

Start date

2021-02-19

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male hypogonadism related to illicit use of anabolic androgenic steroids MedDRA version: 20.0 Level: PT Classification code 10058359 Term: Hypogonadism System Organ Class: 10014698 - Endocrine disorders MedDRA version: 21.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Letrozol "Accord" Product Name: Letrozole Pharmaceutical Form: Capsule INN or Proposed INN: LETROZOLE CAS Number: 112809-51-5 Current Sponsor code: N/A Other descriptive name: Letrozole Co

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • Male sex • 18 – 50 years of age • Hypogonadism following observational period of a minimum of 12 weeks since AAS discontinuation or a urine sample negative for AAS analyses at screening visit: plasma total testosterone = 10 nmol/L AND featuring at least one symptom of male hypogonadism using IIEF in terms of erectile function (IIEF: Q1 – Q5 + Q15; total score =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Established cardiovascular disease • Established diabetes of any kind • Congenital hypogonadal conditions (cryptorchidism, Klinefelter’s disease, Kallmann’s disease etc.) • Previous established hypogonadal conditions due to other causes than illicit use of AAS • Current or previous treatment with testosterone on other indication than AAS-induced male hypogonadism • Abnormal puberty development (small testes, late or absent pubic hairing, late or absent deepening of voice, etc.) • Current or previous pituitary diseases • Current or former testicular cancer • Other cancers unless complete remission = 5 year • Other concomitant disease or treatment which according to the investigators’ assessment makes the patient unsuitable to participate in the study • Simultaneous participation in another clinical study • Unable to follow treatment instructions in terms of study medication instructions • Ongoing criminal behavior in terms of violence or illicit distribution of drugs • Currently or in the foreseeable future included in anti-doping programs

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 ;Secondary Objective: The secondary objectives are: adherence to cessation of AAS use, fertility, cardiac function and quality of life.;Primary end point(s): Change in plasma total testosterone concentration after 24 weeks from baseline ;Timepoint(s) of evaluation of this end point: after 24 weeks	—

Measure

Time frame

Main Objective: 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 ;Secondary Objective: The secondary objectives are: adherence to cessation of AAS use, fertility, cardiac function and quality of life.;Primary end point(s): Change in plasma total testosterone concentration after 24 weeks from baseline ;Timepoint(s) of evaluation of this end point: after 24 weeks

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Secondary

Measure	Time frame
Secondary end point(s): • Group difference in adherence to AAS cessation after 24 and 50 weeks from baseline • Change in total plasma testosterone concentration after 50 weeks from baseline • Change in plasma total testosterone secretion in response to hCG stimulation after 24 and 50 weeks from baseline • Change in basal plasma pituitary gonadotropins, LH and FSH, after 24 and 50 weeks from baseline • Change in secretion of plasma pituitary gonadotropins, LH and FSH, in response to GnRH stimulation after 24 and 50 weeks from baseline • Change in spermatogenesis (sperm count, motility, morphology, sperm acrosome reaction and DNA fragmenting) after 24 and 50 weeks from baseline • Change in testicular size assessed using ultrasound after 24 and 50 weeks • Change in questionnaires scores IIEF (erectile function and libido) and ADAM (hypogonadism) from baseline and after 24 and 50 weeks • Change in questionnaires scores of Major Depression Inventory (MDI) (depression), General Anxiety Disorder 7 (GAD7) (anxiety), Buss-Perry Aggression scale (BPA) (hostility and aggression) and self-administered internet-based Cognition Assessment Tool (ICAT) from baseline and after 24 and 50 weeks • Change in myocardial function assessed by myocardial flow reserve (mL/min/gr) by Rb-82 PET after 24 and 50 weeks from baseline • Change in cardiac systolic function assessed using left ventricular ejection fraction (LVEF) obtained using echocardiography and 24 and 50 weeks from baseline. • Change in cardiac systolic function assessed using left ventricular global longitudinal strain (GLS) obtained using echocardiography and 24 and 50 weeks from baseline. • Change in cardiac structure (left ventricular mass) obtained using echocardiography and 24 and 50 weeks from baseline. ;Timepoint(s) of evaluation of this end point: After 24 weeks and 50 weeks	—

Measure

Time frame

Secondary end point(s): • Group difference in adherence to AAS cessation after 24 and 50 weeks from baseline • Change in total plasma testosterone concentration after 50 weeks from baseline • Change in plasma total testosterone secretion in response to hCG stimulation after 24 and 50 weeks from baseline • Change in basal plasma pituitary gonadotropins, LH and FSH, after 24 and 50 weeks from baseline • Change in secretion of plasma pituitary gonadotropins, LH and FSH, in response to GnRH stimulation after 24 and 50 weeks from baseline • Change in spermatogenesis (sperm count, motility, morphology, sperm acrosome reaction and DNA fragmenting) after 24 and 50 weeks from baseline • Change in testicular size assessed using ultrasound after 24 and 50 weeks • Change in questionnaires scores IIEF (erectile function and libido) and ADAM (hypogonadism) from baseline and after 24 and 50 weeks • Change in questionnaires scores of Major Depression Inventory (MDI) (depression), General Anxiety Disorder 7 (GAD7) (anxiety), Buss-Perry Aggression scale (BPA) (hostility and aggression) and self-administered internet-based Cognition Assessment Tool (ICAT) from baseline and after 24 and 50 weeks • Change in myocardial function assessed by myocardial flow reserve (mL/min/gr) by Rb-82 PET after 24 and 50 weeks from baseline • Change in cardiac systolic function assessed using left ventricular ejection fraction (LVEF) obtained using echocardiography and 24 and 50 weeks from baseline. • Change in cardiac systolic function assessed using left ventricular global longitudinal strain (GLS) obtained using echocardiography and 24 and 50 weeks from baseline. • Change in cardiac structure (left ventricular mass) obtained using echocardiography and 24 and 50 weeks from baseline. ;Timepoint(s) of evaluation of this end point: After 24 weeks and 50 weeks

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Countries

Denmark

Contacts

Public ContactDepartment of Endocrinology

Department of Endocrinology, Rigshospitalet

jon.ras@dadlnet.dk4523602994

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026