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Kisspeptin in the Evaluation of Delayed Puberty

Primary Purpose

Delayed Puberty, Kallmann Syndrome, Hypogonadotropic Hypogonadism

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
kisspeptin 112-121
GnRH
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Delayed Puberty focused on measuring delayed puberty, Kallmann Syndrome, Hypogonadotropic hypogonadism, GnRH Deficiency, kisspeptin, GnRH

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kisspeptin, GnRH

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 24, 2011
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01438034
Brief Title
Kisspeptin in the Evaluation of Delayed Puberty
Official Title
Kisspeptin in the Evaluation of Delayed Puberty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2013 (Actual)
Primary Completion Date
September 8, 2019 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Puberty, Kallmann Syndrome, Hypogonadotropic Hypogonadism, GnRH Deficiency
Keywords
delayed puberty, Kallmann Syndrome, Hypogonadotropic hypogonadism, GnRH Deficiency, kisspeptin, GnRH

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kisspeptin, GnRH
Arm Type
Experimental
Arm Description
Intravenous (IV) administration of kisspeptin 112-121 0.24 nmol/kg and GnRH 75 ng/kg
Intervention Type
Drug
Intervention Name(s)
kisspeptin 112-121
Other Intervention Name(s)
metastin 45-54
Intervention Description
0.24 nmol/kg
Intervention Type
Drug
Intervention Name(s)
GnRH
Intervention Description
75 ng/kg
Primary Outcome Measure Information:
Title
Average change in luteinizing hormone (LH) in response to kisspeptin
Time Frame
Within 30 minutes of administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie B Seminara, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32232399
Citation
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.
Results Reference
derived
PubMed Identifier
29669934
Citation
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.
Results Reference
derived

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Kisspeptin in the Evaluation of Delayed Puberty

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