Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

What Was Tested

This registered phase 2 trial tested 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: 20 planned participants were the target.

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: Ages 18-45 years. Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism). Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg). Negative serum hCG pregnancy test.

The full record lists 8 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.

How the Study Was Run

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

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 2025-12-09 with completion listed for 2030-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change of 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 in 20 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, all human trials.