Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2025-06-18
2025-09-26
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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naloxone
one period of frequent blood sampling with IV administration of naloxone (one bolus)
Naloxone
One bolus of naloxone
Interventions
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Naloxone
One bolus of naloxone
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
MALE
No
Sponsors
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Stephanie B. Seminara, MD
OTHER
Responsible Party
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Stephanie B. Seminara, MD
Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine
Principal Investigators
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Stephanie Seminara, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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313510
Identifier Type: -
Identifier Source: org_study_id