Clinical Trial: Kisspeptin in the Evaluation of Delayed Puberty

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Kisspeptin in the Evaluation of Delayed Puberty

Brief Summary: 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.

Detailed 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.
Sponsor: Massachusetts General Hospital

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

Original Primary Outcome: LH level [ Time Frame: 6 hours ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 ]


Information By: Massachusetts General Hospital

Dates:
Date Received: August 24, 2011
Date Started: November 2011
Date Completion: November 2020
Last Updated: November 18, 2016
Last Verified: November 2016