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

University of California San Diego

Status and phase: Completed; Phase 3

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: recombinant human chorionic gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT00747617

060679

Details and patient eligibility

About

The mechanism for increased androgen production in women with polycystic ovary syndrome (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal women. To test this hypothesis, the investigators propose to conduct a dose-response study in which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH surrogate, will be assessed in PCOS and normal women.

Full description

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, 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 The total amount of blood withdrawn will be about 35 teaspoons.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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

PCOS group

Active Comparator group

Description:

Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions.

Treatment:

Drug: recombinant human chorionic gonadotropin

Control group

Active Comparator group

Description:

Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions.

Treatment:

Drug: recombinant human chorionic gonadotropin