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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Letrozole

Criteria

Inclusion Criteria:

• • Male sex

• 18 - 50 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

Exclusion Criteria:

• 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

• Allergy or hypersensitivity to the active substance (hCG) or excipients of Brevactid® listed in Appendix D

• Established Lapp lactase deficiency or glucose/galactose malabsorption

• Severe venous phlebitis or current or previous venous thromboembolism

• Inguinal hernia

• treatment which according to the investigators' assessment

• 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