Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men

What Was Tested

In this phase 2 trial, researchers set out to test hCG (human chorionic gonadotropin).

It had two arms (groups): Study group (experimental) and Control group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Full Safety profile (see below, the appropriate paragraph). 2.

This parameter will be useful for future clinical studies based on LH. 3.

Comparison of steroid profiles, hormone related profiles and serum levels of testicular steroids upon stimulation by LH or hCG by immunoassay and by LC-MS/MS technique when available as validated method.

The LC-MS/MS technique allows simultaneous detection and quantification of several steroids.

Who Took Part

Enrollment: 32 planned participants were the target.

It was open to men only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Total testosterone serum levels below the normal ranges (lower than 3 ng/mL). No androgen replacement therapies in the last three months before enrolment.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: combined pituitary hormone deficiency; genetic syndromes (e.g., prader-labhart-willi, charge, lawrence-moon- bardet-biedl); drug abuse and major systemic diseases.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

It started in 2022-01-19 with completion listed for 2025-01-18.

It ran at 5 sites in Italy (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Testosterone (time frame: 2 weeks after treatment start). Testosterone (time frame: 4 weeks after treatment start). Testosterone (time frame: 6 weeks after treatment start).

It also tracked 24 secondary outcomes, for example Inhibin B, Inhibin B, Inhibin B, Inhibin B, Free testosterone and Free testosterone.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of hCG (human chorionic gonadotropin) in 32 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.