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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

Tracking Information
First Submitted Date  ICMJE August 24, 2011
First Posted Date  ICMJE September 21, 2011
Last Update Posted Date July 5, 2022
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
Average change in luteinizing hormone (LH) in response to kisspeptin [ Time Frame: Within 30 minutes of administration ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
LH level [ Time Frame: 6 hours ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
  • FSH levels [ Time Frame: 6 hours ]
  • testosterone (males) [ Time Frame: 6 hours ]
  • estradiol (females) [ Time Frame: 6 hours ]
  • CBC [ Time Frame: 1 month ]
  • BUN [ Time Frame: 1 month ]
  • creatinine [ Time Frame: 1 month ]
  • liver function studies [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Kisspeptin in the Evaluation of Delayed Puberty
Official Title  ICMJE Kisspeptin in the Evaluation of Delayed Puberty
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Delayed Puberty
  • Kallmann Syndrome
  • Hypogonadotropic Hypogonadism
  • GnRH Deficiency
Intervention  ICMJE
  • Drug: kisspeptin 112-121
    0.24 nmol/kg
    Other Name: metastin 45-54
  • Drug: GnRH
    75 ng/kg
Study Arms  ICMJE Experimental: kisspeptin
intravenous administration of kisspeptin 112-121 0.24 nmol/kg and GnRH 75 ng/kg
Interventions:
  • Drug: kisspeptin 112-121
  • Drug: GnRH
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2011)
400
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Coordinator 617-726-8484 MGHKisspeptinResearch@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01438034
Other Study ID Numbers  ICMJE 2011P002885
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Stephanie B. Seminara, MD, Massachusetts General Hospital
Original Responsible Party Stephanie B. Seminara, MD, Massachusetts General Hospital, Associate in Medicine
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephanie B Seminara, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP