Status:
TERMINATED
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
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Hypogonadism
Hypogonadism, Male
Eligibility:
MALE
18-50 years
Phase:
PHASE4
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 reproduc...
Detailed Description
A randomized, double-blinded, clinical, placebo-controlled trial enrolling 60 male illicit AAS users with documented AAS-induced hypogonadism after a period \> 12 weeks of AAS cessation or a negative ...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
November 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05205837
Start Date
November 24 2021
End Date
August 15 2023
Last Update
February 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rigshospitalet
Copenhagen, Denmark