Opioid Antagonism in Hypogonadotropic Hypogonadism (NCT04975334) | Clinical Trial Compass
CompletedPhase 1
Opioid Antagonism in Hypogonadotropic Hypogonadism
United States23 participantsStarted 2025-06-18
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Average Change in Mean Luteinizing Hormone (LH) Value