Trial Outcomes & Findings for The Adrenal Contribution to Androgen Production in Girls During Puberty (NCT NCT01062568)
NCT ID: NCT01062568
Last Updated: 2019-08-26
Results Overview
17-hyrooxyprogesterone levels before and after ACTH
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
0 and 60 minutes after ACTH administration
Results posted on
2019-08-26
Participant Flow
Participant milestones
| Measure |
Early Puberty Group
Subjects were subdivided into normal weight and overweight groups. Blood was drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.
Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take a oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements.
|
Late Puberty Group
Subjects were subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.
Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
Dex
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
40
|
|
Overall Study
COMPLETED
|
10
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Early Puberty Group
n=10 Participants
Subjects were subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.
Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
Dex
|
Late Puberty Group
n=40 Participants
Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.
Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
Dex
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Normal Wieght
|
9.8 years
STANDARD_DEVIATION 1 • n=10 Participants
|
13.9 years
STANDARD_DEVIATION 0.9 • n=40 Participants
|
12.1 years
STANDARD_DEVIATION 1 • n=50 Participants
|
|
Age, Continuous
Overweight
|
9.4 years
STANDARD_DEVIATION 0.7 • n=10 Participants
|
14.9 years
STANDARD_DEVIATION 0.4 • n=40 Participants
|
12.4 years
STANDARD_DEVIATION 0.6 • n=50 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
40 Participants
n=40 Participants
|
50 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 0 and 60 minutes after ACTH administrationPopulation: Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls
17-hyrooxyprogesterone levels before and after ACTH
Outcome measures
| Measure |
Early Puberty Group
n=10 Participants
Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
|
Late Puberty Group
n=40 Participants
Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
|
Total Number
n=50 Participants
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
Dex
|
|---|---|---|---|
|
17-hydroxyprogesterone Response to ACTH
Normal Weight
|
2.4 ng/mL
Standard Error 0.5
|
3.7 ng/mL
Standard Error 0.8
|
3.1 ng/mL
Standard Error 0.6
|
|
17-hydroxyprogesterone Response to ACTH
Over Weight
|
2.9 ng/mL
Standard Error 0.4
|
3.1 ng/mL
Standard Error 0.7
|
3.0 ng/mL
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 0 and 60 min after ACTH administrationPopulation: Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls
Free Testosteorne levels before and after ACTH
Outcome measures
| Measure |
Early Puberty Group
n=10 Participants
Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
|
Late Puberty Group
n=40 Participants
Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
|
Total Number
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
Dex
|
|---|---|---|---|
|
Free Testosterone Response to ACTH
Normal weight
|
2 pmol/L
Standard Error 0.3
|
7 pmol/L
Standard Error 1
|
—
|
|
Free Testosterone Response to ACTH
Overweight
|
3.5 pmol/L
Standard Error 0.4
|
32 pmol/L
Standard Error 3
|
—
|
SECONDARY outcome
Timeframe: 0 and 60 min after ACTH administrationPopulation: Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls
Androstenedione levels before and after ACTH
Outcome measures
| Measure |
Early Puberty Group
n=10 Participants
Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
|
Late Puberty Group
n=40 Participants
Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
|
Total Number
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
Dex
|
|---|---|---|---|
|
Androstenedione Response to ACTH
Normal Wieght
|
0.5 ng/mL
Standard Error 0.1
|
1.6 ng/mL
Standard Error 0.3
|
—
|
|
Androstenedione Response to ACTH
Overweight
|
0.6 ng/mL
Standard Error 0.2
|
3.1 ng/mL
Standard Error 0.7
|
—
|
Adverse Events
Early Puberty
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Late Puberty
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