NCT01438034 is a Phase 1 clinical trial of kisspeptin 112-121 in Delayed Puberty, sponsored by Massachusetts General Hospital.

Who is sponsoring NCT01438034?

NCT01438034 is sponsored by Massachusetts General Hospital.

What drugs are being tested in NCT01438034?

Interventions in NCT01438034: kisspeptin 112-121, GnRH.

What condition does NCT01438034 study?

NCT01438034 studies Delayed Puberty, Kallmann Syndrome, Hypogonadotropic Hypogonadism, GnRH Deficiency.

Is NCT01438034 still recruiting?

NCT01438034 is currently completed. Last updated 19 October 2023.

Last reviewed 2023-10-19 · How we verify

NCT01438034

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Kisspeptin in the Evaluation of Delayed Puberty

Completed Phase 1 Last updated 19 October 2023

What this trial tests

Phase 1 trial testing kisspeptin 112-121 in Delayed Puberty in 24 participants. Completed in 10 September 2021.

Timeline

8 June 2013

Primary endpoint
8 September 2019

10 September 2021

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	24
Start date	8 June 2013
Primary completion	8 September 2019
Estimated completion	10 September 2021
Sites	1 location across United States

Drugs / interventions tested

kisspeptin 112-121 — full drug profile →
GnRH — full drug profile →

Conditions studied

Delayed Puberty — all drugs for Delayed Puberty →
Kallmann Syndrome — all drugs for Kallmann Syndrome →
Hypogonadotropic Hypogonadism — all drugs for Hypogonadotropic Hypogonadism →
GnRH Deficiency — all drugs for GnRH Deficiency →

Sponsor

Massachusetts General Hospital

Who can join

Adults 12 to 17, any sex, with Delayed Puberty or Kallmann Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Using Kisspeptin to Predict Pubertal Outcomes for Youth With Pubertal Delay.
Chan YM, Lippincott MF, Sales Barroso P, Alleyn C, et al · · 2020 · cited 35× · PMID 32232399 · DOI 10.1210/clinem/dgaa162
Divergent responses to kisspeptin in children with delayed puberty.
Chan YM, Lippincott MF, Kusa TO, Seminara SB. · · 2018 · cited 15× · PMID 29669934 · DOI 10.1172/jci.insight.99109
Kisspeptin a potential therapeutic target in treatment of both metabolic and reproductive dysfunction.
Sliwowska JH, Woods NE, Alzahrani AR, Paspali E, et al · · 2024 · cited 9× · PMID 38599822 · DOI 10.1111/1753-0407.13541
Kisspeptin Receptor Agonists and Antagonists: Strategies for Discovery and Implications for Human Health and Disease.
Chen X, Yang S, Shaw ND, Xia M. · · 2025 · cited 1× · PMID 40430029 · DOI 10.3390/ijms26104890
SAT-LB110 Sulfonylurea-Induced Hypoglycemia: To Use Octreotide or Not
Romeu J, Dodge H, Mears C, Kozlow E, et al · · 2020
SUN-LB12 Prenatal Trenbolone Exposure and External Genital Malformation: A Case Report
Chilukoti P, Farrell R, Desai R, Omil-Lima D, et al · · 2020
OR11-01 Using Kisspeptin to Predict Pubertal Outcomes for Youth With Pubertal Delay
Chan Y, Lippincott M, Barroso P, Alleyn C, et al · · 2020

Verify or expand the search:

Other trials of kisspeptin 112-121

Trials testing the same drug.

NCT05901467 — Recall by Genotype: Neuropeptide Stimulation · Phase 1 · terminated
NCT05971849 — Dampening the Reproductive Axis With Continuous Kisspeptin · Phase 1 · completed
NCT04648969 — Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism · Phase 2 · completed
NCT00914823 — Kisspeptin Administration in the Adult · Phase 1 · completed

Other Massachusetts General Hospital trials

Trials by the same sponsor.

NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01438034 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 19 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01438034.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing