Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

  • STATUS
    Recruiting
  • End date
    Aug 31, 2026
  • participants needed
    24
  • sponsor
    Stephanie B. Seminara, MD
Updated on 4 March 2021

Summary

The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.

Description

  • Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure.
    • Delivery of Interventions:
    • Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.
    • On the day of the inpatient study, the subjects will
    • Undergo q10 min blood sampling for 6 hours,
    • Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),
    • Undergo q10 min blood samplings for another 6 hours,
    • Receive a single GnRH IV bolus at hour 51.

Details
Condition Hypogonadism, Klinefelter's Syndrome, hypogonadotropic hypogonadism, klinefelter syndrome, secondary hypogonadism
Treatment kisspeptin 112-121, GnRH
Clinical Study IdentifierNCT04648969
SponsorStephanie B. Seminara, MD
Last Modified on4 March 2021

Eligibility

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