Trial Outcomes & Findings for Opioid Antagonism in Hypogonadotropic Hypogonadism (NCT NCT04975334)
NCT ID: NCT04975334
Last Updated: 2026-06-03
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, a 3 hour period on a single study day
Results posted on
2026-06-03
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=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Before and after treatment, a 3 hour period on a single study dayChange 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