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Kisspeptin in the Evaluation of Delayed Puberty

This study is currently recruiting participants.
Verified June 2017 by Stephanie B. Seminara, MD, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438034
First Posted: September 21, 2011
Last Update Posted: June 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital
  Purpose
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 617-724-8592.

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: None (Open Label)
Primary Purpose: Other
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 Stephanie B. Seminara, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Luteinizing hormone (LH) level [ Time Frame: 6 hours ]

Secondary Outcome Measures:
  • Follicle stimulating hormone (FSH) levels [ Time Frame: 6 hours ]
  • testosterone (males) [ Time Frame: 6 hours ]
  • estradiol (females) [ Time Frame: 6 hours ]
  • Complete blood count (CBC) [ Time Frame: 1 month ]
  • Blood urea nitrogen (BUN) [ Time Frame: 1 month ]
  • creatinine [ Time Frame: 1 month ]
  • liver function studies [ Time Frame: 1 month ]
Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2020 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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)
  • adolescent girls (ages 12-17 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
  • weight ≥ 27 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, 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 alcohol or illicit drugs
  • history of an allergic drug reaction
  Contacts and Locations
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
Contact: Tope Kusa, MBBS, MPH 617-726-8622 MGHKisspeptinResearch@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

Responsible Party: Stephanie B. Seminara, MD, Associate in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01438034     History of Changes
Other Study ID Numbers: 2011P002885
First Submitted: August 24, 2011
First Posted: September 21, 2011
Last Update Posted: June 19, 2017
Last Verified: June 2017

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