LH treatment for men with acquired hypogonadotropic hypogonadism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the pharmacodynamics and safety profile of recombinant luteinizing hormone (LH) in men with acquired hypogonadotropic hypogonadism (HH). It aims to determine whether LH supplementation can improve testosterone levels and spermatogenesis compared to traditional treatments like human chorionic gonadotropin (hCG). The study is a multicenter, randomized, open-label trial that will measure serum steroid levels using advanced liquid-chromatography techniques. The primary focus is on assessing the testosterone response to varying doses of LH and comparing it to a fixed dose of hCG.

Why it matters

Who can join: the full rules

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.

Where it's running

• Unit of Endocrinology of Modena
  Modena, Italy Recruiting
• Fondazione IRCCS Ca ' Grande Ospedale Maggiore Policlinico
  Milan, Italy Not yet recruiting
• Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università degli Studi di Napoli "Federico II"
  Naples, Italy Not yet recruiting
• Department of Experimental Medicine, Section of Medical Pathophysiology, Food Science and Endocrinology, Sapienza - University of Rome
  Rome, Italy Not yet recruiting
• ivision of Endocrinology, Diabetes and Metabolism, Department of Medical Science, University of Turin
  Turin, Italy Not yet recruiting

Study contacts

• Study coordinator: Daniele Santi, MD, PhD
• Email: daniele.santi@unimore.it
• Phone: 0593961271

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.