Kisspeptin Administration Subcutaneously to Patients With IHH

What Was Tested

In this phase 2 trial, researchers set out to test Kisspeptin-10 and Leuprolide.

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH).

The investigators are also examining whether kisspeptin can help women release eggs from their ovaries.

Kisspeptin will be administered SC for two weeks in a pulsatile fashion.

It had 1 arm (groups): kisspeptin pump (experimental).

SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes); administration of a single shot of leuprolide acetate (previously GnRH was used in this study).

The registry classes the interventions as drug.

More on the Plan

Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions: * Each subject will undergo a review of their medical history, physical exam, and screening laboratories. * A single SC injection of leuprolide acetate may be administered approximately six days before kisspeptin administration.

Who Took Part

Enrollment: 36 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins. Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg).

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol; excessive alcohol consumption (\>10 drinks/week); active use of illicit drugs (not including marijuana).

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Kisspeptin-10 was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-02-03 with completion listed for 2028-05.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Average change in luteinizing hormone (LH) pulse amplitude (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Kisspeptin-10 and Leuprolide in 36 people.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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