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Kisspeptin-10

KP-10, Metastin (45-54), Kisspeptin-10 (human), KiSS-1

Quick Stats
Studies 877
Trials 47
Completed PHASE1 INTERVENTIONAL NCT01438034

Kisspeptin in the Evaluation of Delayed Puberty

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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. Right now, there is no reliable diagnostic tool to tell whether a child's delayed puberty will be self-resolving or permanent. The hormone kisspeptin has the potential to prospectively diagnose adolescents with self-resolving or permanent delayed puberty.

Detailed Description

The investigators are seeking boys (ages 13.5-17 years) and girls (ages 12-17) years with a diagnosis of delayed puberty. Study participation involves 2 outpatient visits and two hospital admissions (one 11-hour, overnight admission and one 6-hour day admission) when subjects will receive two investigational drugs, the naturally occurring hormones kisspeptin and gonadotropin-releasing hormone (GnRH). 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.

Interventions

Name: kisspeptin 112-121
Type: DRUG
Description: 0.24 nmol/kg
Name: GnRH
Type: DRUG
Description: 75 ng/kg

Primary Outcomes

Measure: Average change in luteinizing hormone (LH) in response to kisspeptin
TimeFrame: Within 30 minutes of administration
Description:

Trial Information

NCT ID

NCT01438034

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Massachusetts General Hospital

Last Updated

December 15, 2025