Clinical trial NCT04975334: Opioid Antagonism in Hypogonadotropic Hypogonadism
Official title: Opioid Antagonism in Hypogonadotropic Hypogonadism
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Hypogonadotropic Hypogonadism
Keywords: Hypogonadotropic Hypogonadism
naloxone
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with idiopathic hypogonadotropic hypogonadism (HH).

Detailed description: Assignment: Each study subject will serve as their own control.

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:

  * Period 1: Undergo q10 min blood sampling for up to 12 hours
  * Period 2: Undergo q10 min blood sampling for up to 12 hours

    * Receive a naloxone bolus followed by a naloxone infusion

Eligibility criteria: Inclusion

* Age 18-75 years
* Confirmed diagnosis of hypogonadotropic hypogonadism
* Genetic sequencing data available
* All medical conditions stable and well controlled
* If applicable, willing to use birth control methods (as approved by a study medical professional) during protocol participation
* Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
* Negative urine drug screening panel
* Hemoglobin
* Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women
* 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
* For women, negative serum hCG pregnancy test

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
* Excessive alcohol consumption (\> 10 drinks/week)
* For women, pregnant or breastfeeding

Primary outcomes:
measure: Average change in Luteinizing Hormone (LH) pulse frequency
timeFrame: Before and during treatment
Secondary outcomes:
measure: Average change in LH pulse amplitude
timeFrame: Before and during treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Stephanie Seminara, MD
role: PRINCIPAL_INVESTIGATOR
References: