Clinical trial: Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men (NCT04189133)

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.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Entailment