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Trial · Interventional

CompletedPhase 1Registry data

Kisspeptin in the Evaluation of Delayed Puberty

NCTNCT01438034 (opens ClinicalTrials.gov in a new tab)Other id2011P002885
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Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
8 Jun 2013
Primary completion
8 Sept 2019
Completion
10 Sept 2021
First posted
21 Sept 2011 (estimated)
Last update posted
19 Oct 2023
Conditions
Delayed Puberty · Kallmann Syndrome · Hypogonadotropic Hypogonadism · GnRH Deficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142016201820202022
  1. Ph 1

    Kisspeptin in the Evaluation of Delayed Puberty

    NCT01438034

    8 Jun 2013 to 10 Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • kisspeptin 112-121Drug
  • GnRHDrug

Arms1

  • Experimental

    Kisspeptin, GnRH

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Average change in luteinizing hormone (LH) in response to kisspeptin

    Time frame · Within 30 minutes of administration

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedChan 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 32232399
  • DerivedChan 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 29669934

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 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 * hemoglobin within reference range for girls of the same chronological age * blood urea nitrogen (BUN), creatinine, prolactin not elevated * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no more than 2X the upper limit of the reference range * Insulin-like growth factor 1 (IGF-1) within reference range for bone age Exclusion Criteria: 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

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