Evaluation of luteinizing hormone effect in me

Phase 1

• Conditions: Aquired hypogonadotropic hypogonadism; MedDRA version: 20.0Level: LLTClassification code 10021012Term: Hypogonadotrophic hypogonadismSystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-004677-12-IT
• Lead Sponsor: IVERSITA' DEGLI STUDI DI MODENA E REGGIO EMILIA - DIPARTIMENTO DI SCIENZE BIOMEDICHE, METABOLICHE E NEUROSCIENZE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

•Male sex
•Age between 18 and 45 years
•Acquired hypogonadotropic hypogonadism forms:
oHypogonadotropic hypogonadism after neurosurgery for tumors (i.e. pituitary adenoma, including prolactinoma, craniopharyngioma, germinomas, meningiomas, gliomas, and astrocytomas). OR
oHypogonadotropic 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

•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 <40% or >54%

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified