Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys.

What Was Tested

This registered phase 3 trial tested Kisspeptin-10.

The specific objective of this study was to investigate the sensitivity of Kisspeptin receptor 1 (KISS1R) by determining the responsiveness of GnRH neuron to kisspeptin administration across the pubertal stages and adult group through measuring plasma LH (luteinizing hormone) and testosterone concentrations.

It had six arms (groups): Tanner Stage I (experimental), Tanner Stage II (experimental), Tanner Stage III (experimental), Tanner Stage IV (experimental) and Tanner stage V (experimental).

The registry classes the interventions as biological.

More on the Plan

Kisspeptin regulates HPG (hypothalamic pituitary gonadal) axis by secreting GnRH that acts on the pituitary gonadotrophs to secrete LH and FSH.

The objective of this study was to determine the response of exogenous kisspeptin in various juvenile stages up to puberty and also in the adults by measuring the level of plasma LH and testosterone.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to men only.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: individuals with chronic illness or disorder, i.e. hepatic and renal complications, epilepsy, pneumonia, asthma, orchitis, hernia, cryptorchidism, mental retardation, etc. were excluded from this study.

How the Study Was Run

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

The Kisspeptin-10 group and the comparison group ran side by side rather than switching.

Being open-label, the Kisspeptin-10 study did not mask who received what.

It started in 2014-06-26 with completion listed for 2014-08-08.

It ran at 1 site in Pakistan.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): To investigate the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration across the pubertal stages and adult group through measuring plasma luteinizing hormone and testosterone concentrations.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Kisspeptin-10 in 30 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Kisspeptin-10 compound page, all human trials.