Overview
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with 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.
- During the study, the subjects will undergo the following:
- Undergo q10 min blood sampling for 3 hours
- Receive a naloxone bolus at the midpoint of q10 min sampling
Eligibility
Inclusion
- Male
- Age 18-75 years
- Confirmed diagnosis of hypogonadotropic hypogonadism (low testosterone)
- Genetic sequencing data available
- All medical conditions stable
- Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
- Negative urine drug screening panel
- Hemoglobin
- 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
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