Opioid Antagonism in Hypogonadotropic Hypogonadism

Launched by STEPHANIE B. SEMINARA, MD · Jul 15, 2021

Keywords

ClinConnect Summary

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.
* During the study, the subjects will undergo the following:

* Period 1: Undergo q10 min blood sampling for up to 12 hours
* Period 2: Undergo q10 min blood sampling for up to 12 hours

* Receive a naloxone bolus followed by a naloxone infusion

Gender

ALL

Eligibility criteria

• • Inclusion
• • Age 18-75 years
• • Confirmed diagnosis of hypogonadotropic hypogonadism
• • Genetic sequencing data available
• • All medical conditions stable and well controlled
• • If applicable, willing to use birth control methods (as approved by a study medical professional) during protocol participation
• • Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
• • Negative urine drug screening panel
• • Hemoglobin
• • Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women
• • Men on adequate testosterone replacement therapy: normal male reference range
• • Men off testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of the reference range for normal women
• • For women, negative serum hCG pregnancy test
• • Exclusion
• • Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
• • Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
• • Current or recent use of a medication that affects the opioid pathway
• • Active illicit drug use
• • Excessive alcohol consumption (\> 10 drinks/week)
• • For women, pregnant or breastfeeding