Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

What Was Tested

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

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA).

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

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

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

SC administration of kisspeptin for two weeks (pulsatile).

The registry classes the interventions as drug.

More on the Plan

Assignment: All study subjects will undergo the same interventions.

Who Took Part

Enrollment: 13 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea). Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg). Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration).

The full record lists 6 inclusion and 5 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) and/or active use of illicit drugs; pregnant or trying to become pregnant.

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 2022-12-16 with completion listed for 2025-08-31.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: The proportion of participants that achieve development of a mature follicle or show evidence of ovulation (time frame: 2 weeks).

It also tracked 1 secondary outcome, for example Change of luteinizing hormone (LH) pulse amplitude.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Kisspeptin-10 in 13 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.