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TerminatedNCT05205837Updated Feb 15, 2024

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

A Phase 4 interventional study of Letrozole 2.5mg, hCG and Placebo in Hypogonadism, Hypogonadism, Male and Hypogonadotropic Hypogonadism, sponsored by Rigshospitalet, Denmark. Terminated at 1 site in Denmark. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-02-15.

Primary conditionEunuchismRegistry: HypogonadismReclassifiedWhy we changed it
Registry
Hypogonadism — the first condition term the registry derived for this study.
ClinicalTrials.gg
Eunuchism
Why
  1. The study's listed conditions name Eunuchism, a narrower term within Hypogonadism.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Rigshospitalet, Denmark · Phase 4, Interventional, and Treatment

Why this study was terminated
Lack of recruitment
Phase
Phase 4
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Hypogonadism
  • Hypogonadism, Male
  • Hypogonadotropic Hypogonadism

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03

In context

Eunuchism Reclassified

75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.

This study's enrollment of 8 is below the median of 60 across 55 interventional studies indexed under Eunuchism.

Browse Eunuchism studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.

Browse Rigshospitalet, Denmark studies →

Compared within Eunuchism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypogonadism. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to the active substance (letrozole) or 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
8 participants (actual)

Study arms

  • Placebo comparator
    Active Comparator - placebo

    Intervention: Intramuscular injection - placebo Intervention: Drug: placebo

    Drug: Placebo

  • Active comparator
    Active comparator - treatment

    Intervention: intramuscular injection - hCG Intervention: Drug: Letrozole

    Drug: Letrozole 2.5mg, hCG

Interventions

  • DrugLetrozole 2.5mg, hCG

    Drug -Treatment Intramuscular injektion - Treatment

  • DrugPlacebo

    Drug - Placebo Intramuscular injektion - placebo

06

What researchers measure

Primary outcomes

  1. Change in plasma total testosterone concentration after 24 weeks from baseline

    Time frame: 24 weeks

Secondary outcomes

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

    Time frame: 24 and 50 weeks

  2. Change in total plasma testosterone concentration after 50 weeks from baseline

    Time frame: 50 weeks

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

    Time frame: 24 and 50 weeks

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

    Time frame: 24 and 50 weeks

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

    Time frame: 24 and 50 weeks

  6. Change in sperm count after 24 and 50 weeks from baseline

    Time frame: 24 and 50 weeks

  7. Change in sperm motility after 24 and 50 weeks from baseline

    Time frame: 24 and 50 weeks

  8. Change in sperm morphology after 24 and 50 weeks from baseline

    Time frame: 24 and 50 weeks

  9. Change in sperm acrosome reaction after 24 and 50 weeks from baseline

    Time frame: 24 and 50 weeks

  10. Change in sperm DNA fragmenting after 24 and 50 weeks from baseline

    Time frame: 24 and 50 weeks

  11. Change in testicular size assessed using ultrasound after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  12. Change in questionnaire score IIEF (erectile function and libido) from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  13. Change in questionnaire score ADAM (hypogonadism) from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  14. Change in questionnaire score of Major Depression Inventory (MDI) (depression) from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  15. Change in questionnaire score of (GAD7) (anxiety) from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  16. Change in questionnaire score of Buss-Perry Aggression scale (BPA) (hostility and aggression) from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  17. Change in questionnaire score of COBRA (Cognitive complaints in bipolar disorder rating assessment) from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  18. Change in questionnaire score of the Health Assessment Short Form-36 questionnaire from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  19. Change in questionnaire score of Body-Q 349 (Perception of own body) from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  20. Change in questionnaire score of the Inventory of Interpersonal Problems 32-item (IIP32) from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  21. Change in myocardial function assessed by myocardial flow reserve (mL/min/gr) by Rb-82 PET from baseline and after 24 and 50 weeks

    Time frame: 24 and 50 weeks

  22. Change in cardiac systolic function assessed using left ventricular ejection fraction (LVEF) obtained using echocardiography and 24 and 50 weeks from baseline.

    Time frame: 24 and 50 weeks

  23. Change in cardiac systolic function assessed using left ventricular global longitudinal strain (GLS) obtained using echocardiography and 24 and 50 weeks from baseline.

    Time frame: 24 and 50 weeks

  24. Change in cardiac structure (left ventricular mass) obtained using echocardiography and 24 and 50 weeks from baseline.

    Time frame: 24 and 50 weeks

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2021 to primary completion in Aug 2023, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2021
First posted
Jan 25, 2022
StartActual
Nov 24, 2021
Primary completionActual
Aug 15, 2023
CompletionActual
Aug 15, 2023
Last update
Feb 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05205837
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Caroline Michaela Kistorp (Professor, Rigshospitalet, Denmark) — Principal investigator
First posted
Jan 25, 2022
Start date
Nov 24, 2021
Primary completion
Aug 15, 2023
Completion
Aug 15, 2023
Last update
Feb 15, 2024

Study contacts

Caroline Michaela Kistorp, professor, MD
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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