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Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction

NCT01422733 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2018-07-19

No results posted yet for this study

Summary

This study will test whether longer-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight early pubertal girls with androgen excess. The investigators hypothesize that suppression of nighttime adrenocorticotropin hormone (ACTH) production by 12 weeks of evening oral hydrocortisone administration will improve androgen levels in girls with adrenal androgen overproduction. Specifically, this intervention will improve androgen levels after adrenal stimulation testing with ACTH or ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).

Conditions

  • Hyperandrogenemia
  • Obesity
  • Polycystic Ovary Syndrome

Interventions

DRUG

Hydrocortisone

10mg/m2/per day PO at bedtime (X12 weeks)

DRUG

dexamethasone

1 mg PO twice

DRUG

Cosyntropin

250 micrograms IV twice

DRUG

rhCG

25 mcg IV twice

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Christine Burt Solorzano, MD · University of Virginia

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-07-17
Completion
2018-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422733 on ClinicalTrials.gov