Aquired hypogonadotropic hypogonadism MedDRA version: 20.0 Level: LLT Classification code 10021012 Term: Hypogonadotrophic hypogonadism System Organ Class: 100000004860
Conditions
Interventions
Trade Name: LUVERIS - 75 IU/ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO + 1 FIALA USO SOTTOCUTANEO
Product Name: Luveris
Product Code: [034951]
Pharmaceutical Form: Powder and solvent
Sponsors
UNIVERSITA' DEGLI STUDI DI MODENA E REGGIO EMILIA - DIPARTIMENTO DI SCIENZE BIOMEDICHE, METABOLICHE E NEUROSCIENZE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male sex • Age between 18 and 45 years • Acquired hypogonadotropic hypogonadism forms: o Hypogonadotropic hypogonadism after neurosurgery for tumors (i.e. pituitary adenoma, including prolactinoma, craniopharyngioma, germinomas, meningiomas, gliomas, and astrocytomas). OR o Hypogonadotropic hypogonadism due to pituitary adenoma-related mass effect, in case of cured or controlled hormone hypersecretion • Total testosterone serum levels below the normal ranges (lower than 3 ng/mL) • No androgen replacement therapies in the last three months before enrolment. On the other hand, when the patient was treated with intramuscular testosterone formulations, they must be changed into gel formulations at least in the six months before enrolment. When the patient was treated with androgens in gel formulations, they must be stopped 15 days before enrolment. • No current hyper-secretion of other pituitary hormones Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Congenital hypogonadotropic hypogonadism forms, such as: Congenital combined pituitary hormone deficiency; Genetic syndromes (e.g., Prader-Labhart-Willi, CHARGE, Lawrence-Moon-Bardet-Biedl) • Acquired HH forms due to Infiltrative disease (hemochromatosis, granulomatous disease, histiocytosis, and sarcoidosis) • Use of anabolic steroids and/or chronic non-replacement steroid therapies • Drug and alcohol abuse • Major systemic diseases, such as chronic severe liver disease, active malignancy diseases, cardiac failure, hypertension, renal dysfunction, migraines, or epilepsy (since aggravation or recurrence may occasionally be induced as a result of increased androgen production) • Concomitant illnesses which could interfere with the study participation • Medical history of androgen-dependent tumors (i.e. male breast carcinoma or prostatic carcinoma) • Haematocrit 54%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the pharmacodynamics of recombinant LH, comparing the response to LH and hCG in hypogonadotropic hypogonadism patients and to evaluate LH safety profile. The results of this study are necessary for future clinical trials to test the hypothesis that, being the physiological hormone, the addition of LH improves the stimulation of spermatogenesis compared to FSH alone in infertile men and compared to FSH+hCG in HH. The patients with hypogonadotropic hypogonadism object of this study are simultaneously the best model for pharmacodynamics of LH/hCG and are representative of both male infertility and hypogonadism. The pharmacodynamics of LH and the comparison of response to LH and hCG will be assessed by measuring serum steroid levels by liquid-chromatography, tandem mass spectrometry (LC-MS/MS).;Secondary Objective: 1.Full Safety profile 2.Identification of the LH dosages needed to restore normal testosterone production in men with acquired hypogonadotropic hypogonadism and of the relationship between LH administered and testosterone increase, e.g. in terms of % serum testosterone increase per IU of r-hLH. This parameter will be useful for future clinical studies based on LH. 3.Comparison of steroid profiles, hormone related profiles and serum levels of testicular steroids upon stimulation by LH or hCG by immunoassay and by LC-MS/MS technique when available as validated method. 4.Testicular size;Primary end point(s): The primary outcome measure of the study will be the total testosterone serum levels increase, centrally measured by LC-MS/MS at each visit. Indeed, the primary endpoint of the study will be the comparison of total testosterone increase during LH administration to what obtained by hCG treatment. Moreover, primary endpoint will be the detection of a dose-response curve of testosterone increase during LH administration.;Timepoint(s) of evaluation of this end point: Two times weekly during the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Inhibin B, free testosterone, LH, FSH, estradiol, anti-Mullerian hormone (AMH); Safety and tolerability as determined by AE, SAE reporting, vital signs, ECG, Concomitant medication, laboratory parameters should be included in each panel (e.g., for haematology, chemistry, urinalysis) and evaluation of anti-Human-LH Antibodies formation in the serum.; • Red blood cell count • Markers of liver and renal function • Markers of coagulation • 1,25 and 25 Hydroxy-vitamin D serum levels, INSL-3; Testicular volume;Timepoint(s) of evaluation of this end point: Two times weekly during the treatment phase and one time every two weeks in the washout phase; Two times weekly during the treatment phase and one time every two weeks in the washout phase; Two times weekly during the treatment phase and one time every two weeks in the washout phase; Baseline, at the end of treatment phase, at the end of washout phase | — |
Countries
Italy
Contacts
Public ContactComitato Etico
Comitato Etico dell'Area Vasta Emilia Nord
Outcome results
None listed