Kisspeptin in the Evaluation of Delayed Puberty

This study is currently recruiting participants. (see Contacts and Locations)
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

August 24, 2011
January 13, 2014
November 2011
November 2014   (final data collection date for primary outcome measure)
Luteinizing hormone (LH) level [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
LH level [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01438034 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • CBC [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Kisspeptin in the Evaluation of Delayed Puberty
Kisspeptin in the Evaluation of Delayed Puberty

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
  • Delayed Puberty
  • Kallmann Syndrome
  • Hypogonadotropic Hypogonadism
  • GnRH Deficiency
Drug: kisspeptin 112-121
0.24 nmol/kg
Other Name: metastin 45-54
Experimental: kisspeptin
intravenous administration of kisspeptin 112-121 0.24 nmol/kg.
Intervention: Drug: kisspeptin 112-121
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
13 Years to 17 Years
No
Contact: Stephanie B Seminara, MD (617) 724-8304 sseminara@partners.org
United States
 
NCT01438034
2010-P-001453
Yes
Stephanie B. Seminara, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Stephanie B Seminara, MD Massachusetts General Hospital
Massachusetts General Hospital
January 2014

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