Overview
Sponsor-declared trial summary
Hypogonadotropic hypogonadism
The general clinical question is whether LH supplementation could be more efficient than hCG in those cases in which LH-activity is required, such as men with HH or male infertility. Since LH has never been used in men so far, the primary object of this study is the assessment of pharmacodynamics of human recombinant L…
Key facts
- Sponsor
- Department Of Biomedical Metabolic And Neural Sciences
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- completed 4 Apr 2025
- Decision date (initial)
- 2025-01-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518159-52-02
- EudraCT number
- 2019-004677-12
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacodynamic
The general clinical question is whether LH supplementation could be more efficient than hCG in those cases in which LH-activity is required, such as men with HH or male infertility. Since LH has never been used in men so far, the primary object of this study is the assessment of pharmacodynamics of human recombinant LH in men. To this end, this study will evaluate the pharmacodynamics of recombinant LH (Luveris) and compare the response to Luveris and urinary hCG (Gonasi HP), the latter representing the standard of care, in terms of testosterone serum levels. Men with HH men are the best model for this comparison. Pharmacodynamics will be assessed primarily by testosterone levels in response to increasing doses of LH and in comparison to hCG.
Secondary objectives 1
- Identification of the LH dosages needed to restore normal testosterone production in men with acquired HH and of the relationship between LH administered and testosterone increase, e.g. in terms of % serum testosterone increase per IU of LH. 2. Identification of the hCG dosages needed to restore normal testosterone production in men with acquired HH and of the relationship between hCG administered and testosterone increase, e.g. in terms of % serum testosterone increase per IU of hCG. 3. Testicular size 4. Full Safety profile (see below, the appropriate paragraph).
Conditions and MedDRA coding
Hypogonadotropic hypogonadism
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518159-52-00 | Pharmacodynamics and safety of human recombinant luteinising hormone in hypogonadotropic hypogonadal men | Department Of Biomedical Metabolic And Neural Sciences |
| 2024-518159-52-01 | Pharmacodynamics and safety of human recombinant luteinising hormone in hypogonadotropic hypogonadal men | Department Of Biomedical Metabolic And Neural Sciences |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Hypogonadotropic hypogonadism
Exclusion criteria 1
- Iatrogenic HH forms, such as traumatic pituitary stalk interruption syndrome, irradiation, high dose corticosteroids, and anabolic steroids Drug abuse and major systemic diseases Chronic severe liver disease Concomitant illnesses which could interfere with the study participation Active malignancy diseases Known or possible androgen-dependent tumors for example male breast carcinoma or prostatic carcinoma Cardiac failure, hypertension, renal dysfunction, migraines, or epilepsy. (since aggravation or recurrence may occasionally be induced as a result of increased androgen production) Haematocrit <40% or >54% Syndromic congenital HH are excluded since these genetic forms of HH could be related to other systemic diseases, which could bias the selection of patients. 12 Hypersensitivity to any of the component of the two IMPs (including excipients) Hypothalamic or pituitary cancer Active thrombophlebitis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Total testosterone serum levels
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP8246432 · ATC
- Active substance
- Lutropin Alfa
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 IU/l international unit(s)/litre
- Max total dose
- 10500 IU/l international unit(s)/litre
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03GA07 — LUTROPIN ALFA
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Department Of Biomedical Metabolic And Neural Sciences
- Sponsor organisation
- Department Of Biomedical Metabolic And Neural Sciences
- Address
- Via Giuseppe Campi 287
- City
- Modena
- Postcode
- 41125
- Country
- Italy
Scientific contact point
- Organisation
- Department Of Biomedical Metabolic And Neural Sciences
- Contact name
- Clinical trial information
Public contact point
- Organisation
- Department Of Biomedical Metabolic And Neural Sciences
- Contact name
- Clinical trial information
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 1 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Rhythm_Final Report SUM-110594
|
2025-12-11T10:04:23 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Rhythm_Lay person summary of results | 2025-12-11T10:04:18 | Submitted | Laypersons Summary of Results |
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Rhythm_Lay person summary of results_11-12-25 | 1 |
| Protocol (for publication) | 2_Protocollo_versione 5 del 05-10-23_clean_signed | 1 |
| Recruitment arrangements (for publication) | 8- Lettera al MMG_versione 2 del 05-10-23_clean_signed | 1 |
| Subject information and informed consent form (for publication) | Consent_versione 3 del 05-10-2023 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Spc_Luveris | 1 |
| Summary of results (for publication) | Rhythm_Final Report_21-11-25_Final | 1 |
| Synopsis of the protocol (for publication) | Synopsis | 4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-04 | Italy | Acceptable 2025-01-21
|
2025-01-27 |