Administration of Kisspeptin in Patients With Hyperprolactinemia

What Was Tested

This registered phase 2 trial tested Kisspeptin-10 for hyperparathyroidism.

The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia).

Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration).

Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.

It had two arms (groups): Intravenous Kisspeptin (experimental) and Subcutaneous Kisspeptin (experimental).

Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 intravenously (IV).

Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 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.

The full record lists 0 inclusion and 8 exclusion criteria; among the exclusions: confirmed diagnosis of elevated levels of prolactin measured via blood test,; no pituitary adenoma or a microprolactinoma (\<10 mm). patients with a macroprolactinoma confirmed on mri imaging will be excluded,; no history of a medication reaction requiring emergency medical care,.

How the Study Was Run

It was run as a non-randomized, sequential and open-label study.

Nothing was hidden in this open-label Kisspeptin-10 study: the hyperparathyroidism participants and staff both knew the treatment.

It started in 2017-11-17 with completion listed for 2023-06-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours (time frame: Up to 14 days). Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin (time frame: Evaluated over eight days).

It also tracked 1 secondary outcome, for example Average Change in LH Pulse Amplitude.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Kisspeptin-10 in 36 people with hyperparathyroidism.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Kisspeptin-10 compound page, Hyperparathyroidism research.