Trial Outcomes & Findings for Opioid Antagonism in Hypogonadotropic Hypogonadism (NCT NCT04975334)
NCT ID: NCT04975334
Last Updated: 2026-05-01
Results Overview
Change in mean LH before vs. after naloxone bolus
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Before and after treatment
Results posted on
2026-05-01
Participant Flow
Boston area. 23 participants were consented and screened for eligibility between 6/2025 and 8/2025.
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.
Participant milestones
| Measure |
Naloxone
one period of frequent blood sampling with IV administration of naloxone (one bolus)
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Opioid Antagonism in Hypogonadotropic Hypogonadism
Baseline characteristics by cohort
| Measure |
Naloxone
n=9 Participants
one period of frequent blood sampling with IV administration of naloxone (one bolus)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Before and after treatmentChange in mean LH before vs. after naloxone bolus
Outcome measures
| Measure |
Naloxone
n=9 Participants
one period of frequent blood sampling with IV administration of naloxone (one bolus)
|
|---|---|
|
Average Change in Mean Luteinizing Hormone (LH) Value
|
1.571 IU/L
Standard Deviation 2.714
|
Adverse Events
Naloxone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place