The Adrenal Contribution to Androgen Production in Girls During Puberty

NCT01062568 | Completed Phase 3 Results DMC

• 1 other identifier: 091676
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Development

Keywords

adolescents; puberty; androgens; hyperandrogenemia

Outcome Measures

Primary Outcomes (1)

• 17-hydroxyprogesterone Response to ACTH

  17-hyrooxyprogesterone levels before and after ACTH

  0 and 60 minutes after ACTH administration

Secondary Outcomes (2)

• Free Testosterone Response to ACTH

  0 and 60 min after ACTH administration

• Androstenedione Response to ACTH

  0 and 60 min after ACTH administration

Study Arms (2)

Obese group

EXPERIMENTAL

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.

Drug: Adrenocorticotropin; Drug: Dexamethasone

Nonobese group

EXPERIMENTAL

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.

Drug: Adrenocorticotropin; Drug: Dexamethasone

Interventions

Adrenocorticotropin DRUG

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.

Also known as: Cosyntropin, ACTH

Nonobese group; Obese group

Dexamethasone DRUG

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.

Also known as: dex

Nonobese group; Obese group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of california, san diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Interventions

Adrenocorticotropic Hormone; Cosyntropin; Dexamethasone

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. R. Jeffery Chang
• Organization: UCSD

rjchang@ucsd.edu

858-534-8930

Study Officials

• R J Chang, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 26, 2019
• Results First Posted: August 26, 2019

Record last verified: 2019-08

Locations

US (1)