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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

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

ArmDescriptionAssigned Intervention
Experimental
naloxone 		one period of frequent blood sampling with IV administration of naloxone (one bolus)
  • Drug: Naloxone
    One bolus of naloxone

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Study Coordinator
617-643-2308
MGHReproEndoResearch@mgb.org

More Details

Status
Recruiting
Sponsor
Stephanie B. Seminara, MD

Study Contact

Study Coordinator
617-643-2308
MGHReproEndoResearch@mgb.org

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.