Kisspeptin in the Evaluation of Delayed Puberty

This study is currently recruiting participants.
Verified January 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01438034
First received: August 24, 2011
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

The investigators are seeking boys (ages 14-17 years) and girls (ages 13-17) 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 617-724-8592.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Kisspeptin in the Evaluation of Delayed Puberty

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Luteinizing hormone (LH) level [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Follicle stimulating hormone (FSH) levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • testosterone (males) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • estradiol (females) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Complete blood count (CBC) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Blood urea nitrogen (BUN) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • creatinine [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • liver function studies [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: kisspeptin
intravenous administration of kisspeptin 112-121 0.24 nmol/kg.
Drug: kisspeptin 112-121
0.24 nmol/kg
Other Name: metastin 45-54

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adolescent boys (ages 14-17 years)
  • adolescent girls (ages 13-17 years)
  • testicular volume <4 mL OR 4-8 ml with no change in the past 6 months by Prader orchidometer (boys), Tanner stage I OR II breast development with no change in the past 6 months girls)
  • first morning (before 9AM) LH <2 mIU/mL and testosterone <50 ng/dL (boys) estradiol <20 pg/ml (girls)
  • bone age less than chronological age
  • height and weight >5th percentile and <95th percentile for bone age, weight >= 39 kg
  • body mass index >10th percentile and <95th percentile for bone age
  • blood pressure >5th percentile and <95th percentile for bone age and height
  • white blood cell counts, platelet counts, erythrocyte sedimentation rate, electrolytes, thyroid stimulating hormone (TSH), free thyroxine (T4) within reference range for age
  • hemoglobin within reference range for girls of the same chronological age
  • blood urea nitrogen (BUN), creatinine, prolactin no more than 1.25X the upper limit of the reference range for age
  • 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:

  • history or presence of underlying condition that could cause delayed puberty (chronic illness, weight loss, abnormal cranial magnetic resonance imaging (MRI))
  • use of any oral prescription medication (with the exception of antihistamines or allergies) within the prior 2 months
  • use of alcohol or illicit drugs
  • history of an allergic drug reaction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438034

Contacts
Contact: Stephanie B Seminara, MD (617) 724-8304 sseminara@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yee-Ming Chan, MD, PhD    617-726-9260    ymchan@partners.org   
Principal Investigator: Stephanie B Seminara, MD         
Sub-Investigator: Yee-Ming Chan, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Stephanie B Seminara, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Stephanie B. Seminara, MD, Associate in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01438034     History of Changes
Other Study ID Numbers: 2010-P-001453
Study First Received: August 24, 2011
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Puberty, Delayed
Kallmann Syndrome
Gonadal Disorders
Endocrine System Diseases
46, XY Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 15, 2014