Kisspeptin Administration in the Adult

What Was Tested

In this phase 1 trial, researchers set out to test Kisspeptin-10 for hyperparathyroidism and pcos.

The goal of this study is to learn about the role of kisspeptin in the reproductive system.

Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body.

It had 1 arm (groups): kisspeptin, GnRH (experimental).

Intravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH.

The registry classes the interventions as drug.

More on the Plan

The reproductive hormone GnRH is essential for normal reproductive function.

People with idiopathic hypogonadotropic hypogonadism (IHH), hyperprolactinemia, and polycystic ovarian syndrome (PCOS) do not secrete or respond to GnRH in a normal way.

In this study, investigators will give participants kisspeptin-a hormone that is naturally found in the human body and is known to be a powerful stimulus of GnRH secretion.

They may also give participants GnRH to determine if participants will be able to fully respond to kisspeptin.

Who Took Part

Enrollment: 256 actual participants took part.

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

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

Examples of who could join: Normal puberty with respect to onset and pace,. No chronic diseases,. No difficulty with blood draws,. No prescription medications for at least 2 months with the exception of seasonal allergy medications and hormone replacement therapy,. No illicit drug use or excessive alcohol consumption (\< 10 drinks/week),.

The full record lists 44 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2009-06-23 with completion listed for 2021-10-22.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Average change in luteinizing hormone (LH) in response to kisspeptin (time frame: Within 30 minutes of administration).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Kisspeptin-10 in 256 people with hyperparathyroidism.

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, Hyperparathyroidism research, PCOS research.