LH treatment for men with acquired hypogonadotropic hypogonadism
Pharmacodynamics and Safety of Human Recombinant Luteinising Hormone in Hypogonadotropic Hypogonadal Men
This study is testing if a new hormone treatment can boost testosterone levels and sperm production in men with low hormone levels compared to a standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Azienda Ospedaliero-Universitaria di Modena Academic / other |
| Locations | 5 sites (Milan and 4 other locations) |
| Trial ID | NCT04189133 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 to 45 with acquired forms of hypogonadotropic hypogonadism, particularly those with a history of neurosurgery for tumors.
Not a fit: Patients with genetic syndromes, combined pituitary hormone deficiency, or those who have undergone certain medical treatments that induce hypogonadotropic hypogonadism may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance testosterone production and fertility outcomes in men suffering from acquired hypogonadotropic hypogonadism.
How similar studies have performed: While LH has not been previously used in men, studies on hCG have shown positive outcomes, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan and 4 other locations
- Fondazione IRCCS Ca ' Grande Ospedale Maggiore Policlinico — Milan, Italy (Not_yet_recruiting)
- Unit of Endocrinology of Modena — Modena, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.