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
  • End date
    Dec 23, 2023
  • participants needed
    60
  • sponsor
    Rigshospitalet, Denmark
Updated on 23 March 2022
testosterone
testosterone level
hormone levels
male hypogonadism
screening procedure

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.

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 urine AAS doping test. Participants will be randomized to two study groups; 24 weeks of treatment with either tablet letrozole (femar®) initial dose of 2.5 mg each day versus tablet placebo. After an initial treatment period of four weeks, intramuscular injections with either hCG, initial dose 1500 IE twice weekly (letrozole group) or isotonic saline twice weekly (placebo group) will be added to therapy if plasma total testosterone level has not increased to target plasma level. Following 24 weeks of therapy, all participants will be observed for another 26 weeks without therapy. The study will have one trial center of recruitment: Department of Endocrinology, Rigshospitalet. Following participation in the study, all participants will be offered referral to an endocrine outpatient clinic if they still display clinical and biochemical signs of male hypogonadism.

A healthy group of 30 young lean eugonadal men, who have never used AAS, will be enrolled as control participants and undergo a screening visit and one visit including same procedures as the screening and randomization visits.

Details
Condition Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
Treatment Placebo, Letrozole 2.5mg, hCG
Clinical Study IdentifierNCT05205837
SponsorRigshospitalet, Denmark
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

• Male sex
- 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note