Trial Outcomes & Findings for Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities (NCT NCT00054756)
NCT ID: NCT00054756
Last Updated: 2018-08-08
Results Overview
Serum TSH Levels in Response to TRH Administration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
180 minutes from infusion
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
Thyrotropin Releasing Hormone
Subjects receiving TRH (Thyrotropin Releasing Hormone)
|
|---|---|
|
Overall Study
STARTED
|
96
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two participants did not report sex.
Baseline characteristics by cohort
| Measure |
Thyrotropin Releasing Hormone
n=96 Participants
Subjects receiving TRH (Thyrotropin Releasing Hormone)
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=96 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
92 Participants
n=96 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=96 Participants
|
|
Age, Continuous
|
38 years
n=96 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=94 Participants • Two participants did not report sex.
|
|
Sex: Female, Male
Male
|
36 Participants
n=94 Participants • Two participants did not report sex.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=96 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=96 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=96 Participants
|
PRIMARY outcome
Timeframe: 180 minutes from infusionPopulation: 2 participants did not have results drawn at 180 minutes
Serum TSH Levels in Response to TRH Administration
Outcome measures
| Measure |
Thyrotropin Releasing Hormone
n=94 Participants
Subjects receiving TRH (Thyrotropin Releasing Hormone)
|
|---|---|
|
TSH Response to TRH
|
11.47 mcIU/mL
Interval 0.01 to 233.0
|
Adverse Events
Thyrotropin Releasing Hormone
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