CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled / 23 target
Drug / intervention
Naloxonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04975334
NCT04975334Phase 1CompletedHigh Momentum (1.9/mo)Completion was 9mo ago
CompareCT.gov

Opioid Antagonism in Hypogonadotropic Hypogonadism

Stephanie B. Seminara, MD·interventional·Posted Jul 23, 2021·Updated Jun 3, 2026

In Brief

A Phase 1 clinical trial evaluating Naloxone for Hypogonadotropic Hypogonadism and Low Testosterone. Completed, enrolled 23 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadotropic Hypogonadism, Low Testosterone
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJul 23, 2021
Enrollment StartJun 18, 2025
Primary CompletionSep 26, 2025
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.9 years ago

Arms & Interventions

naloxoneexperimental

one period of frequent blood sampling with IV administration of naloxone (one bolus)

Drug: Naloxone

Interventions

Naloxonedrug

One bolus of naloxone