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

Phase 3
12 Years
18 Years
Open (Enrolling)

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Trial Information

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

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) levels. Studies to determine the alteration in ovarian steroidogenesis
that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene
expression with accentuated 17-hydroxylase activity leading to exaggerated
17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast,
T and A responses did not distinguish between PCOS and normal women, although these
androgens were clearly greater in the former compared to the latter group. As a result, 17P
responsiveness has been employed to determine the functional capacity of the ovary to
produce androgens. The stimulatory agents that have been used included GnRH agonist,
Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU.We propose to
conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG
after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls.
This will allow for a comparison of these adolescents' ovarian functional capacity to
produce androgens.

Inclusion Criteria:

- Normal CBC (Hemoglobin must be at least 11mg/dl)

- Normal renal and liver function tests

- Normal vital signs including normal blood pressure

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:


Outcome Description:

Assess serum levels of 17OHP after stimulation with recombinant hCG

Outcome Time Frame:

24 hours

Safety Issue:


Principal Investigator

R. Jeffery Chang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSD School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

August 2011

Completion Date:

July 2014

Related Keywords:

  • PCOS
  • PCOS
  • oligomenorrhea
  • irregular menses
  • hyperandrogenemia
  • elevated testosterone
  • adolescents
  • androgens
  • ovary
  • LH
  • Polycystic Ovary Syndrome



UCSD School of MedicineLa Jolla, California  92093-0663