Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA · Dec 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a hormone called LH (luteinizing hormone) in men who have a condition known as acquired hypogonadotropic hypogonadism (HH), which means their bodies don't produce enough testosterone. The main goal is to see if adding LH to the usual treatment (FSH, or follicle-stimulating hormone) can help improve testosterone levels and increase the chances of pregnancy, either naturally or with assisted reproductive techniques. The trial will compare how well LH works against another hormone treatment called hCG.

To participate, men aged 18 to 45 with specific types of acquired HH, such as those who have had surgery for tumors affecting the pituitary gland, may be eligible. Participants will be randomly assigned to receive either increasing doses of LH or a standard dose of hCG over eight weeks, with regular check-ins to monitor their health. The study will also keep track of any side effects and how well each treatment works. It's important to note that there are certain health conditions that would exclude someone from this trial, such as severe liver disease or active cancer.

Gender

MALE

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.