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
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
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
NCT ID
NCT01438034
First Posted
August 24, 2011
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
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
Learn more about this trial
Kisspeptin in the Evaluation of Delayed Puberty
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