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Kisspeptin in the Evaluation of Delayed Puberty

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ClinicalTrials.gov Identifier: NCT01438034
Recruitment Status : Recruiting
First Posted : September 21, 2011
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Delayed Puberty Kallmann Syndrome Hypogonadotropic Hypogonadism GnRH Deficiency Drug: kisspeptin 112-121 Drug: GnRH Phase 1

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. Individuals interested in learning more may call 617-726-8484.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Kisspeptin in the Evaluation of Delayed Puberty
Study Start Date : November 2011
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Puberty

Arms and Interventions
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Arm Intervention/treatment
Experimental: kisspeptin
intravenous administration of kisspeptin 112-121 0.24 nmol/kg and GnRH 75 ng/kg
 Drug: kisspeptin 112-121
0.24 nmol/kg
Other Name: metastin 45-54

Drug: GnRH
75 ng/kg


Outcome Measures
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Primary Outcome Measures :
  1. Average change in luteinizing hormone (LH) in response to kisspeptin [ Time Frame: Within 30 minutes of administration ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438034


Contacts
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Contact: Study Coordinator 617-726-8484 MGHKisspeptinResearch@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yee-Ming Chan, MD, PhD    617-726-9260    YMCHAN@mgh.harvard.edu   
Principal Investigator: Stephanie B Seminara, MD         
Sub-Investigator: Yee-Ming Chan, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Stephanie B Seminara, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01438034    
Other Study ID Numbers: 2011P002885
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kallmann Syndrome
Hypogonadism
Puberty, Delayed
Gonadal Disorders
Endocrine System Diseases
 Disorder of Sex Development, 46,XY
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn