HypogonadismPhase 4NCT05205837
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 study testing Letrozole 2.5mg, hCG in people with Hypogonadism and Hypogonadism, Male, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
- What is being tested?
- Letrozole 2.5mg, hCG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Nov 2021to 15 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- 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.)
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 on Plasma Reproductive Hormones, Fertility, Withdrawal Symptoms and Myocardial Function - The LUCAS Trial
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.
- Being tested
- Letrozole 2.5mg, hCG, Placebo
- Medical subject headings
- Hypogonadism, Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole 2.5mg, hCGDrug
Drug -Treatment Intramuscular injektion - Treatment
PlaceboDrug
Drug - Placebo Intramuscular injektion - placebo
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator - placebo | Placebo comparator | Intervention: Intramuscular injection - placebo Intervention: Drug: placebo Receives: Drug: Placebo |
| Active comparator - treatment | Active comparator | Intervention: intramuscular injection - hCG Intervention: Drug: Letrozole Receives: Drug: Letrozole 2.5mg, hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma total testosterone concentration after 24 weeks from baseline
Measured: 24 weeks
Secondary outcomes (24)
Number of participants who adhere to AAS cessation after 24 and 50 weeks from baseline
Measured: 24 and 50 weeks
Change in total plasma testosterone concentration after 50 weeks from baseline
Measured: 50 weeks
Change in plasma total testosterone secretion in response to hCG stimulation after 24 and 50 weeks from baseline
Measured: 24 and 50 weeks
Change in basal plasma pituitary gonadotropins, LH and FSH, after 24 and 50 weeks from baseline
Measured: 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
Measured: 24 and 50 weeks
Change in sperm count after 24 and 50 weeks from baseline
Measured: 24 and 50 weeks
Change in sperm motility after 24 and 50 weeks from baseline
Measured: 24 and 50 weeks
Change in sperm morphology after 24 and 50 weeks from baseline
Measured: 24 and 50 weeks
Change in sperm acrosome reaction after 24 and 50 weeks from baseline
Measured: 24 and 50 weeks
Change in sperm DNA fragmenting after 24 and 50 weeks from baseline
Measured: 24 and 50 weeks
Change in testicular size assessed using ultrasound after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in questionnaire score IIEF (erectile function and libido) from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in questionnaire score ADAM (hypogonadism) from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in questionnaire score of Major Depression Inventory (MDI) (depression) from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in questionnaire score of (GAD7) (anxiety) from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in questionnaire score of Buss-Perry Aggression scale (BPA) (hostility and aggression) from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in questionnaire score of COBRA (Cognitive complaints in bipolar disorder rating assessment) from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in questionnaire score of the Health Assessment Short Form-36 questionnaire from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in questionnaire score of Body-Q 349 (Perception of own body) from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in questionnaire score of the Inventory of Interpersonal Problems 32-item (IIP32) from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in myocardial function assessed by myocardial flow reserve (mL/min/gr) by Rb-82 PET from baseline and after 24 and 50 weeks
Measured: 24 and 50 weeks
Change in cardiac systolic function assessed using left ventricular ejection fraction (LVEF) obtained using echocardiography and 24 and 50 weeks from baseline.
Measured: 24 and 50 weeks
Change in cardiac systolic function assessed using left ventricular global longitudinal strain (GLS) obtained using echocardiography and 24 and 50 weeks from baseline.
Measured: 24 and 50 weeks
Change in cardiac structure (left ventricular mass) obtained using echocardiography and 24 and 50 weeks from baseline.
Measured: 24 and 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start24 Nov 2021
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Michaela Kistorp, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Caroline Michaela Kistorp, professor, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205837
- Sponsor's protocol ID
- H-20036287
- Other IDs
- 2020-002612-52
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2021
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 on Plasma Reproductive Hormones, Fertility, Withdrawal Symptoms and Myocardial Function - The LUCAS Trial
- ClinicalTrials.gov ID
- NCT05205837
- Acronym / sponsor ID
- H-20036287
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
| Arm | Type | Receives |
|---|---|---|
| Active Comparator - placebo | Placebo comparator | Drug: PlaceboIntervention: Intramuscular injection - placebo Intervention: Drug: placebo |
| Active comparator - treatment | Active comparator | Drug: Letrozole 2.5mg, hCGIntervention: intramuscular injection - hCG Intervention: Drug: Letrozole |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Male sex
Key exclusion criteria (24 listed)
- Established cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole 2.5mg, hCGDrug -Treatment Intramuscular injektion - Treatment | Drug | Active comparator - treatment |
| PlaceboDrug - Placebo Intramuscular injektion - placebo | Drug | Active Comparator - placebo |
Primary outcome
Change in plasma total testosterone concentration after 24 weeks from baseline
Time frame: 24 weeks
24 secondary outcomes
Number of participants who adhere to AAS cessation after 24 and 50 weeks from baseline
Time frame: 24 and 50 weeks
Change in total plasma testosterone concentration after 50 weeks from baseline
Time frame: 50 weeks
Change in plasma total testosterone secretion in response to hCG stimulation after 24 and 50 weeks from baseline
Time frame: 24 and 50 weeks
Change in basal plasma pituitary gonadotropins, LH and FSH, after 24 and 50 weeks from baseline
Time frame: 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
Time frame: 24 and 50 weeks
Change in sperm count after 24 and 50 weeks from baseline
Time frame: 24 and 50 weeks
Change in sperm motility after 24 and 50 weeks from baseline
Time frame: 24 and 50 weeks
Change in sperm morphology after 24 and 50 weeks from baseline
Time frame: 24 and 50 weeks
Change in sperm acrosome reaction after 24 and 50 weeks from baseline
Time frame: 24 and 50 weeks
Change in sperm DNA fragmenting after 24 and 50 weeks from baseline
Time frame: 24 and 50 weeks
Change in testicular size assessed using ultrasound after 24 and 50 weeks
Time frame: 24 and 50 weeks
Change in questionnaire score IIEF (erectile function and libido) from baseline and after 24 and 50 weeks
Time frame: 24 and 50 weeks
Change in questionnaire score ADAM (hypogonadism) from baseline and after 24 and 50 weeks
Time frame: 24 and 50 weeks
Change in questionnaire score of Major Depression Inventory (MDI) (depression) from baseline and after 24 and 50 weeks
Time frame: 24 and 50 weeks
Change in questionnaire score of (GAD7) (anxiety) from baseline and after 24 and 50 weeks
Time frame: 24 and 50 weeks
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
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
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
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
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
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
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
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
Change in cardiac structure (left ventricular mass) obtained using echocardiography and 24 and 50 weeks from baseline.
Time frame: 24 and 50 weeks
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Michaela Kistorp, professor, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole 2.5mg, hCG in people with Hypogonadism and Hypogonadism, Male, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma total testosterone concentration after 24 weeks from baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.