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- The LUCAS Trial

NCT05205837 | Terminated Phase 4 DMC

• 2 other identifiers: H-200362872020-002612-52
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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, adherence to cessation of AAS use, fertility, cardiac function and quality of life.

Conditions

Hypogonadism; Hypogonadism, Male; Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Change in plasma total testosterone concentration after 24 weeks from baseline

  24 weeks

Secondary Outcomes (24)

• Number of participants who adhere to AAS cessation after 24 and 50 weeks from baseline

  24 and 50 weeks

• Change in total plasma testosterone concentration after 50 weeks from baseline

  50 weeks

• Change in plasma total testosterone secretion in response to hCG stimulation after 24 and 50 weeks from baseline

  24 and 50 weeks

• Change in basal plasma pituitary gonadotropins, LH and FSH, after 24 and 50 weeks from baseline

  24 and 50 weeks

• Change in secretion of plasma pituitary gonadotropins, LH and FSH, in response to GnRH stimulation after 24 and 50 weeks from baseline

  24 and 50 weeks

Study Arms (2)

Active Comparator - placebo

PLACEBO COMPARATOR

Intervention: Intramuscular injection - placebo Intervention: Drug: placebo

Drug: Placebo

Active comparator - treatment

ACTIVE COMPARATOR

Intervention: intramuscular injection - hCG Intervention: Drug: Letrozole

Drug: Letrozole 2.5mg, hCG

Interventions

Letrozole 2.5mg, hCG DRUG

Drug -Treatment Intramuscular injektion - Treatment

Active comparator - treatment

Placebo DRUG

Drug - Placebo Intramuscular injektion - placebo

Active Comparator - placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male sex
• years of age
• Hypogonadism following observational period of a minimum of 12 weeks since AAS discontinuation OR hypogonadism with 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 \< 26) and/or sexual desire (IIEF: Q11 + Q12; total \< 7) (1) and/or ADAM questionnaire (YES to three questions other than question 1 and 7) and/or regular use of medical treatment for erectile dysfunction.
• Motivation for permanent AAS cessation

You may not qualify if:

• Established cardiovascular disease
• Established diabetes of any kind 384
• 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 including pituitary tumors
• Current or previous tumors of the hypothalamus
• Current or former testicular cancer
• Current or previous prostate cancer
• Current or previous breast cancer
• Other cancers unless complete remission ≥ 5 year
• Other concomitant disease or makes the patient unsuitable to participate in the study
• Severely impaired liver function
• Allergy or hypersensitivity to the active substance (letrozole) or excipients of Letrozol "Accord"® listed in Appendix D

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Hypogonadism; Eunuchism

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Caroline Michaela Kistorp, professor, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 25, 2022
• Study Start: November 24, 2021
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)