Clinical Trial: Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

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

Official Title: Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Brief Summary:

The investigators are seeking subjects for a study of the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that stimulates the production of reproductive hormones. Continuous administration of kisspeptin paradoxically suppresses the reproductive endocrine axis temporarily. By administering 24-hour infusions of kisspeptin, the investigators hope to learn more about the role of kisspeptin both in normal physiology and pathological conditions.

The investigators are initially seeking healthy men, healthy women with regular menstrual cycles, and healthy postmenopausal women. In a later part of the study, the investigators will also enroll subjects with reproductive disorders. Study participation involves 2 outpatient visits and one 38-hour hospital admission when subjects will receive kisspeptin and Gonadotropin releasing hormone (GnRH).

Individuals interested in learning more may call 617-724-8592.


Detailed Summary: Please contact study staff for a detailed description.
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: September 2011
Date Completion: September 2017
Last Updated: October 18, 2016
Last Verified: October 2016