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Kisspeptin in the Evaluation of Delayed Puberty

This study is currently recruiting participants.
Verified March 2013 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: March 12, 2013
Last verified: March 2013
History of Changes
  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
 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:

MedlinePlus related topics: Puberty
U.S. FDA Resources

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 <90th 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: March 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Puberty, Delayed
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 13, 2013