Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

What Was Tested

In this phase 1 trial, researchers set out to test Kisspeptin-10.

The investigators are looking for subjects to complete a study on the role of kisspeptin in the reproductive system.

Kisspeptin is a naturally occurring hormone in humans that tells the body to produce other reproductive hormones.

However, giving someone a continued amount of kisspeptin over a period of time can have the opposite effect and tell the body to, for a short time, stop making hormones needed for reproduction.

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

The registry classes the interventions as drug.

More on the Plan

Please contact study staff for a detailed description.

Who Took Part

The registry lists 96 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Normal puberty with respect to onset and pace,. No difficulty with blood draws,. No prescription medications for at least 2 months with the exception of asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication,. No illicit drug use or excessive alcohol consumption (\>10 drinks/week),. No history of a medication reaction requiring emergency medical care,.

The full record lists 35 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a single-group and open-label study.

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 2011-09 with completion listed for 2016-04.

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 difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion (time frame: 24 hours).

It also tracked 2 secondary outcomes, for example Average difference in testosterone concentration at the beginning and end of kisspeptin infusion (males) and Average difference in estradiol concentration at the beginning and end of kisspeptin infusion (females).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Kisspeptin-10 in 96 people.

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.