Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men (RHYTHM)
Acquired Hypogonadotropic Hypogonadism
About this trial
This is an interventional treatment trial for Acquired Hypogonadotropic Hypogonadism focused on measuring luteinising hormone, male infertility, hypogonadotropic hypogonadism, human menopausal gonadotropin
Eligibility Criteria
Inclusion Criteria:
- Male sex
- Age between 18 and 45 years
- Acquired HH forms
- HH after neurosurgery for tumors (i.e. pituitary adenoma, including prolactinoma, craniopharyngioma, germinomas, meningiomas, gliomas, and astrocytomas). Infiltrative disease (hemochromatosis, granulomatous disease, histiocytosis, and sarcoidosis), OR
- HH 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
- No hyper-secretion of other pituitary hormones
Exclusion Criteria:
HH forms, such as:
- Combined pituitary hormone deficiency
- Genetic syndromes (e.g., Prader-Labhart-Willi, CHARGE, Lawrence-Moon- Bardet-Biedl)
- 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%
- Congenital HH are excluded since these genetic forms of HH could be related to other systemic or pituitary diseases, which could bias the selection of patients.
Sites / Locations
- Fondazione IRCCS Ca ' Grande Ospedale Maggiore Policlinico
- Unit of Endocrinology of ModenaRecruiting
- Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università degli Studi di Napoli "Federico II"
- Department of Experimental Medicine, Section of Medical Pathophysiology, Food Science and Endocrinology, Sapienza - University of Rome
- ivision of Endocrinology, Diabetes and Metabolism, Department of Medical Science, University of Turin
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Study group
Control group
The study group will receive the daily administration sc of Luveris with increasing dosages two weeks (Treatment phase) as follows: Rec-LH 75 IU daily for 2 weeks; Rec-LH 150 IU daily for 2 weeks; Rec-LH 300 IU daily for 2 weeks; Rec-LH 600 IU daily for 2 weeks.
The control group will receive the administration im of Gonasi HP as follows: hCG 500 IU two times weekly, for 2 weeks; hCG 1000 IU two times weekly, for 2 weeks; hCG 1500 IU two times weekly, for 2 weeks; hCG 2000 IU two times weekly, for 2 weeks.