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Pharmacodynamics and safety of human recombinant luteinising hormone in hypogonadotropic hypogonadal men
EU CTIS ID: 2024-518159-52-02
What this study is testing
The general clinical question is whether LH supplementation could be more efficient than hCG in those cases in which LH-activity is required, such as men with HH or male infertility. Since LH has never been used in men so far, the primary object of this study is the assessment of pharmacodynamics of human recombinant LH in men. To this end, this study will evaluate the pharmacodynamics of recombinant LH (Luveris) and compare the response to Luveris and urinary hCG (Gonasi HP), the latter representing the standard of care, in terms of testosterone serum levels. Men with HH men are the best model for this comparison. Pharmacodynamics will be assessed primarily by testosterone levels in response to increasing doses of LH and in comparison to hCG.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Hypogonadotropic hypogonadism
You likely can't join if
- 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% Syndromic congenital HH are excluded since these genetic forms of HH could be related to other systemic diseases, which could bias the selection of patients. 12 Hypersensitivity to any of the component of the two IMPs (including excipients) Hypothalamic or pituitary cancer Active thrombophlebitis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.