The Adrenal Contribution to Androgen Production in Girls During Puberty

Development Clinical Trial

Official title:

The Adrenal Contribution to Androgen Production in Girls During Puberty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062568
• Other study ID #: 091676
• Status: Completed
• Phase: Phase 3
• Start date: February 2010
• Est. completion date: July 2014

Study information

• Verified date: August 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Development

Intervention

Drug:
• 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.
• Dexamethasone
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, 0.25 mg 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.

Locations

Country	Name	City	State
United States	University of california, san diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17-hydroxyprogesterone Response to ACTH	17-hyrooxyprogesterone levels before and after ACTH	0 and 60 minutes after ACTH administration
Secondary	Free Testosterone Response to ACTH	Free Testosteorne levels before and after ACTH	0 and 60 min after ACTH administration
Secondary	Androstenedione Response to ACTH	Androstenedione levels before and after ACTH	0 and 60 min after ACTH administration