NCT01438034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 8, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

6.3 years

First QC Date

August 24, 2011

Last Update Submit

October 17, 2023

Conditions

Delayed PubertyKallmann SyndromeHypogonadotropic HypogonadismGnRH Deficiency

Keywords

delayed pubertyKallmann SyndromeHypogonadotropic hypogonadismGnRH DeficiencykisspeptinGnRH

Outcome Measures

Primary Outcomes (1)

  • Average change in luteinizing hormone (LH) in response to kisspeptin

    Within 30 minutes of administration

Study Arms (1)

Kisspeptin, GnRH

EXPERIMENTAL

Intravenous (IV) administration of kisspeptin 112-121 0.24 nmol/kg and GnRH 75 ng/kg

Drug: kisspeptin 112-121Drug: GnRH

Interventions

kisspeptin 112-121DRUG

0.24 nmol/kg

Also known as: metastin 45-54
Kisspeptin, GnRH
GnRHDRUG

75 ng/kg

Kisspeptin, GnRH

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescent Boys
  • ages 13.5-17 years
  • testicular volume \<4 mL OR 4-8 ml with no change in the past 6 months by Prader orchidometer
  • first morning (before 9AM) LH \<2 mIU/mL and testosterone \<50 ng/dL
  • Adolescent Girls
  • ages 12-17 years
  • Tanner stage I OR II breast development with no change in the past 6 months
  • first morning (before 9AM) LH \<2 mIU/mL and estradiol \<20 pg/ml
  • All Subjects:
  • bone age less than chronological age
  • weight ≥ 28 kg
  • body mass index \>10th percentile and \<+3 SDS for bone age
  • blood pressure \>5th percentile and \<95th percentile for bone age and height
  • white blood cell counts, platelet counts, electrolytes, thyroid stimulating hormone (TSH), free thyroxine (T4) within reference range for age
  • erythrocyte sedimentation rate \<2X the upper limit of the reference range for age
  • +4 more criteria

You may not qualify if:

  • All Subjects:
  • history or presence of underlying condition that could cause delayed puberty (chronic illness, weight loss, abnormal cranial magnetic resonance imaging (MRI))
  • history of an allergic drug reaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Chan YM, Lippincott MF, Sales Barroso P, Alleyn C, Brodsky J, Granados H, Roberts SA, Sandler C, Srivatsa A, Seminara SB. Using Kisspeptin to Predict Pubertal Outcomes for Youth With Pubertal Delay. J Clin Endocrinol Metab. 2020 Aug 1;105(8):e2717-25. doi: 10.1210/clinem/dgaa162.

    PMID: 32232399DERIVED

  • Chan YM, Lippincott MF, Kusa TO, Seminara SB. Divergent responses to kisspeptin in children with delayed puberty. JCI Insight. 2018 Apr 19;3(8):e99109. doi: 10.1172/jci.insight.99109. eCollection 2018 Apr 19.

    PMID: 29669934DERIVED

MeSH Terms

Conditions

Puberty, DelayedKallmann SyndromeHypogonadism

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesDisorder of Sex Development, 46,XYDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Stephanie B Seminara, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

First Submitted

August 24, 2011

First Posted

September 21, 2011

Study Start

June 8, 2013

Primary Completion

September 8, 2019

Study Completion

September 10, 2021

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)