Trial Summary
What is the purpose of this trial?
This trial uses hormone injections and naloxone to study their effects on people with low reproductive hormone levels due to an unknown cause. Kisspeptin and GnRH help increase hormone production, while naloxone blocks opioid effects. The goal is to understand how these treatments affect hormone levels in these patients.
Research Team
Stephanie B. Seminara, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for adults with low testosterone or estradiol due to hypogonadotropic hypogonadism (HH), who are not currently seeking fertility, and have stable medical conditions. Participants should not be on medications affecting reproductive functions, have no history of severe medication reactions, and must pass certain blood tests.Inclusion Criteria
I can stop my hormone therapy for a certain period if needed.
Women must have a negative pregnancy test before joining the study, and another test may be done before taking the medication.
I haven't taken drugs affecting my hormones except for treating my reproductive condition.
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Treatment Details
Interventions
- GnRH (Gonadotropin-releasing Hormone Agonist)
- Kisspeptin, GnRH (Gonadotropin-releasing Hormone Agonist)
- Naloxone (Opioid Antagonist)
Trial OverviewThe study is testing the impact of opioid antagonists like naloxone on the hormonal axis in people with idiopathic HH. It aims to understand how blocking opioids affects hormones that control reproductive functions using substances such as kisspeptin and GnRH.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: naloxoneExperimental Treatment1 Intervention
one period of frequent blood sampling with no medication administered; one period of frequent blood sampling with IV administration of naloxone (one bolus and an infusion over an up to 12-hour period.)
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Who Is Running the Clinical Trial?
Stephanie B. Seminara, MD
Lead Sponsor
Trials
10
Recruited
840+