Neuropeptides in Human Reproduction

What Was Tested

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

The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system.

Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone.

The researchers hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.

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

Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 61 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Ages 21-40 (healthy men and regularly cycling women) OR ages 18-75 (men and women with hypogonadotropic hypogonadism (HH)). Normal blood pressure (systolic BP \<140 mm Hg, diastolic BP \<90 mm Hg). Negative urine drug screen panel. For healthy men and healthy regularly cycling women: normal. For men and women with HH: No less than 0.5 gm/dL below the lower limit of the reference range for normal women.

The full record lists 11 inclusion and 7 exclusion criteria; among the exclusions: history of medication reaction requiring emergency medical attention; illicit drug use; consumption of more than 10 alcoholic drinks per week.

How the Study Was Run

The set-up was single-group and open-label.

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 2014-04-30 with completion listed for 2016-05-31.

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 before and after 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 61 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.