Hypogonadotropic Hypogonadism, Low Testosterone
Conditions
Keywords
Hypogonadotropic Hypogonadism, naloxone
Brief 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).
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: * Undergo q10 min blood sampling for 3 hours * Receive a naloxone bolus at the midpoint of q10 min sampling
Interventions
DRUGNaloxone
One bolus of naloxone
Sponsors
Stephanie B. Seminara, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Mean Luteinizing Hormone (LH) Value | Before and after treatment, a 3 hour period on a single study day | Change in mean LH before vs. after naloxone bolus |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephanie Seminara, MD
Massachusetts General Hospital
Participant flow
Recruitment details
Boston area. 23 participants were consented and screened for eligibility between 6/2025 and 8/2025.
Pre-assignment details
There was no washout or run-in period. 14 individuals were not assigned to an arm because they withdrew or were found to be ineligible by criteria.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
None listed