Opioid Antagonism in Hypogonadotropic Hypogonadism

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    23
  • sponsor
    Stephanie B. Seminara, MD
Updated on 7 July 2022
pituitary
klinefelter syndrome
secondary hypogonadism
idiopathic hypogonadotropic hypogonadism
kisspeptin

Summary

The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with idiopathic hypogonadotropic hypogonadism (HH).

Description

Assignment: Each study subject will serve as their own control.

Delivery of Interventions:

  • Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
  • On the days of the inpatient study, the subjects will
  • Day 1: Undergo q10 min blood sampling for 13 hours
  • Receive 3 kisspeptin intravenous (IV) boluses
  • Receive 1 Gonadotropin Releasing Hormone (GnRH) IV bolus
  • Day 2: Undergo q10 min blood sampling for 13 hours
  • Receive a naloxone bolus followed by a naloxone infusion
  • Receive 3 kisspeptin IV boluses
  • Receive 1 GnRH IV bolus

Details
Condition Hypogonadotropic Hypogonadism
Treatment GnRH, naloxone, kisspeptin, GnRH, naloxone
Clinical Study IdentifierNCT04975334
SponsorStephanie B. Seminara, MD
Last Modified on7 July 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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