Status:

COMPLETED

Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)

Lead Sponsor:

University of California, San Diego

Collaborating Sponsors:

University of Virginia

Conditions:

PCOS

Eligibility:

FEMALE

12-18 years

Phase:

PHASE3

Brief Summary

In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) level...

Detailed Description

In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) level...

Eligibility Criteria

Inclusion

  • Normal CBC (Hemoglobin must be at least 11mg/dl)
  • Normal renal and liver function tests
  • Normal vital signs including normal blood pressure

Exclusion

  • 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)

Key Trial Info

Start Date :

August 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2014

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT01154192

Start Date

August 1 2011

End Date

September 1 2014

Last Update

April 30 2019

Active Locations (1)

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UCSD School of Medicine

La Jolla, California, United States, 92093