Primary outcomeMean· 0 and 60 minutes after ACTH administration
17-hydroxyprogesterone Response to ACTH
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Early Puberty Group | 2.4 | 0.5 |
| Late Puberty Group | 3.7 | 0.8 |
| Total Number | 3.1 | 0.6 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataThe Adrenal Contribution to Androgen Production in Girls During Puberty
NCTNCT01062568 (opens ClinicalTrials.gov in a new tab)Other id091676
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 50 participants (actual)
- Sponsor
- University of California, San Diego · Other
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Feb 2010
- Primary completion
- Jul 2014
- Completion
- Jul 2014
- First posted
- 4 Feb 2010 (estimated)
- Last update posted
- 26 Aug 2019
- Conditions
- Development
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201020112012201320142015
- Ph 3
The Adrenal Contribution to Androgen Production in Girls During Puberty
NCT01062568Feb 2010 to Jul 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.
Interventions
- AdrenocorticotropinDrug
- DexamethasoneDrug
Arms2
Experimental
Obese group
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.
Experimental
Nonobese group
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
17-hydroxyprogesterone Response to ACTH
Time frame · 0 and 60 minutes after ACTH administration
Registry description
17-hyrooxyprogesterone levels before and after ACTH
Secondary outcomes(2)
Free Testosterone Response to ACTH
Time frame · 0 and 60 min after ACTH administration
Registry description
Free Testosteorne levels before and after ACTH
Androstenedione Response to ACTH
Time frame · 0 and 60 min after ACTH administration
Registry description
Androstenedione levels before and after ACTH
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeMean· 0 and 60 min after ACTH administration
Free Testosterone Response to ACTH
| Group | Value (pmol/L) | Spread |
|---|---|---|
| Early Puberty Group | 2 | 0.3 |
| Late Puberty Group | 7 | 1 |
Secondary outcomeMean· 0 and 60 min after ACTH administration
Androstenedione Response to ACTH
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Early Puberty | 0.5 | 0.1 |
| Late Puberty | 1.6 | 0.3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Early PubertySubjects 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. . | 0 / 10 | 0 / 10 | 0 / 10 |
| Late PubertySubjects 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. | 0 / 40 | 0 / 40 | 0 / 40 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 7 Years up to 18 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Normal CBC (Hemoglobin must be at least 11mg/dl)
* Normal renal and liver function tests (AST\& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;
* direct bili \<0.2 mg/dL;
* total bili \<1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)
Exclusion Criteria:
* Pregnancy
* On oral contraceptives
* On insulin lowering drugs
* On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
* On medications that will influence androgen metabolism or clearance
* On medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconazole, etc)
* Subjects with morning cortisol\<5 ug/dL will be excluded and asked to see their primary care physician.
* Subjects with 17-OHP\>250 ng/dL) will be excluded and asked to see their primary care physician.
* Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded
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