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Theca Cell Function in Women With Polycystic Ovary Syndrome


Phase 3
18 Years
35 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

Theca Cell Function in Women With Polycystic Ovary Syndrome


Each subject (normal and PCOS women) will be admitted to the UCSD General Clinical Research
Center (GCRC) for study on 5 occasions. All subjects will receive an intravenous injection
of hCG dose of 1, 10, 25, 100, and 250 micrograms, each of which will be given on one of 5
different days each separated by at least two weeks at 8 AM. Blood samples will be obtained
at t -0.5, 0, 0.5,and 24 hours after injection. All visits to the GCRC will be done as out
patients. The total amount of blood withdrawn will be about 35 teaspoons. For normal
control subjects this will be over a period of about 4-6 months and for PCOS subjects this
will be over a period of about 6-10 weeks.


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:

- No oral contraceptives

- No insulin lowering drugs

- No anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)

- No medications that will influence androgen metabolism or clearance

- No medications that will inhibit the cytochrome P450 enzyme system (cimetidine,
ketoconozole, etc)

- No use of clomiphene citrate within 3 months prior to study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Serum 17OHP Responses to hCG

Outcome Description:

Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects

Outcome Time Frame:

24 hrs post dose

Safety Issue:

No

Principal Investigator

R, Jeffrey Chang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSD SChool of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

060679

NCT ID:

NCT00747617

Start Date:

September 2007

Completion Date:

September 2010

Related Keywords:

  • Polycystic Ovary Syndrome
  • polycystic ovary syndrome
  • androgens
  • ovary
  • LH
  • Polycystic Ovary Syndrome

Name

Location
University of California, San Diego, School of Medicine La Jolla, California  92093