Kisspeptin in the Evaluation of Delayed Puberty

What Was Tested

The trial (phase 1) is built around Kisspeptin-10.

The goal of this study is to test whether the hormone kisspeptin has the potential to prospectively diagnose adolescents with self-resolving or permanent delayed puberty.

Some children with delayed puberty will eventually enter puberty on their own.

However, some children with delayed puberty have a permanent condition and require medical treatment to undergo puberty.

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

The registry classes the interventions as drug.

More on the Plan

The investigators are seeking boys (ages 13.5-17 years) and girls (ages 12-17) years with a diagnosis of delayed puberty.

Subjects will then be followed every 6 months until they reach 18 years of age to determine if their pubertal delay was self-resolved or permanent.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 12 years up to 17 years.

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

Examples of who could join: Ages 13.5-17 years. First morning (before 9AM) LH \<2 mIU/mL and testosterone \<50 ng/dL. Ages 12-17 years. Tanner stage I OR II breast development with no change in the past 6 months. First morning (before 9AM) LH \<2 mIU/mL and estradiol \<20 pg/ml.

The full record lists 16 inclusion and 2 exclusion criteria; among the exclusions: history or presence of underlying condition that could cause delayed puberty (chronic illness, weight loss, abnormal cranial magnetic resonance imaging (mri)); history of an allergic drug reaction.

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 2013-06-08 with completion listed for 2019-09-08.

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 24 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.