Phase 3
N=50
The Adrenal Contribution to Androgen Production in Girls During Puberty
Development
Bottom Line
View on ClinicalTrials.gov: NCT01062568 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: 17-hydroxyprogesterone Response to ACTH — 2.4; 3.7; 3.1; 2.9 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adrenocorticotropin (Drug); Dexamethasone (Drug)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 17-hydroxyprogesterone Response to ACTH |
2.4; 3.7; 3.1; 2.9; 3.1; 3.0 | — |
| SECONDARY Free Testosterone Response to ACTH |
2; 7; 3.5; 32 | — |
| SECONDARY Androstenedione Response to ACTH |
0.5; 1.6; 0.6; 3.1 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01062568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.