Opioid Antagonism in Hypogonadotropic Hypogonadism

Stephanie B. Seminara, MD

Status and phase

Completed

Phase 1

Conditions

Low Testosterone

Hypogonadotropic Hypogonadism

Treatments

Drug: Naloxone

Study type

Interventional

Funder types

Other

Identifiers

NCT04975334

313510

Details and patient eligibility

About

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).

Full 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

Enrollment

23 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

Male
Age 18-75 years
Confirmed diagnosis of hypogonadotropic hypogonadism (low testosterone)
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