Opioid Antagonism in Hypogonadotropic Hypogonadism
Purpose
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).
Conditions
- Hypogonadotropic Hypogonadism
- Low Testosterone
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
Criteria
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental naloxone |
one period of frequent blood sampling with IV administration of naloxone (one bolus) |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Stephanie B. Seminara, MD
Detailed 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