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

Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: recombinant human chorionic gonadotropin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of California, San Diego

Official(s) and/or principal investigator(s):
R, Jeffrey Chang, M.D., Principal Investigator, Affiliation: UCSD SChool of Medicine

Summary

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.

Clinical Details

Official title: Theca Cell Function in Women With Polycystic Ovary Syndrome

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

Primary outcome: Serum 17OHP Responses to hCG

Secondary outcome: Serum Testosterone Responses to hCG

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 The total amount of blood withdrawn will be about 35 teaspoons.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

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

University of California, San Diego, School of Medicine, La Jolla, California 92093, United States
Additional Information

Related publications:

Chang RJ. The reproductive phenotype in polycystic ovary syndrome. Nat Clin Pract Endocrinol Metab. 2007 Oct;3(10):688-95. Review.

Wachs DS, Coffler MS, Malcom PJ, Shimasaki S, Chang RJ. Increased androgen response to follicle-stimulating hormone administration in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 May;93(5):1827-33. doi: 10.1210/jc.2007-2664. Epub 2008 Feb 19.

Wachs DS, Coffler MS, Malcom PJ, Chang RJ. Comparison of follicle-stimulating-hormone-stimulated dimeric inhibin and estradiol responses as indicators of granulosa cell function in polycystic ovary syndrome and normal women. J Clin Endocrinol Metab. 2006 Aug;91(8):2920-5. Epub 2006 May 23.

Mehta RV, Malcom PJ, Chang RJ. The effect of androgen blockade on granulosa cell estradiol production after follicle-stimulating hormone stimulation in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Sep;91(9):3503-6. Epub 2006 Jun 27.

Mehta RV, Patel KS, Coffler MS, Dahan MH, Yoo RY, Archer JS, Malcom PJ, Chang RJ. Luteinizing hormone secretion is not influenced by insulin infusion in women with polycystic ovary syndrome despite improved insulin sensitivity during pioglitazone treatment. J Clin Endocrinol Metab. 2005 Apr;90(4):2136-41. Epub 2005 Jan 11.

Chang RJ. A practical approach to the diagnosis of polycystic ovary syndrome. Am J Obstet Gynecol. 2004 Sep;191(3):713-7. Review.

Starting date: September 2007
Last updated: January 28, 2013

Page last updated: August 23, 2015

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