Phase 1
N=9
Opioid Antagonism in Hypogonadotropic Hypogonadism
Hypogonadotropic Hypogonadism · Low Testosterone
Bottom Line
View on ClinicalTrials.gov: NCT04975334 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Average Change in Mean Luteinizing Hormone (LH) Value — 1.571 IU/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Naloxone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Stephanie B. Seminara, MD
- Primary completion
- Sep 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change in Mean Luteinizing Hormone (LH) Value |
1.571 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04975334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.