Theca Cell Function in Women With Polycystic Ovary Syndrome - Full Text View

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00747617

Purpose

The mechanism for increased androgen production in women with PCOS is not well understood. Excess androgn production by the ovary is stimulated by increased pituitary 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 hCG, an LH surrogate, will be assessed in PCOS and normal women.

Condition	Intervention	Phase
Polycystic Ovary Syndrome	Drug: human chorionic gonadotropin	Phase III

Drug Information available for: Chorionic gonadotropin Choriogonadotropin Alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Theca Cell Function in Women With Polycystic Ovary Syndrome

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

Serum 17OHP responses to hCG [ Time Frame: -0.5, 0, 0.5, 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum testosterone responses to hCG [ Time Frame: -0.5, 0, 0.5, 24 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, 1: PCOS: Experimental PCOS women receiving multi-dose hCG	Drug: human chorionic gonadotropin Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
A, 2: Normal: Experimental Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.	Drug: human chorionic gonadotropin Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.

Detailed Description:

Each subject (normal and PCOS women) will be admitted to the UCSD General Clinical Research Center 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

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747617

Contacts

Contact: Annette Haggan, R.N.	858-534-8972	aramoshaggan@ucsd.edu
Contact: R. Jeffrey Chang, M.D.	858-534-8930	rjcahng@ucsd.edu

Locations

United States, California
University of California, San Diego, School of Medicine	Recruiting
La Jolla, California, United States, 92093
Contact: Annette Haggan, R.N. 858-534-8972 aramoshaggan@ucsd.edu
Contact: R. Jeffrey Chang, M.D. 85-534-8930 rjchang@ucsd.edu
Principal Investigator: R. Jeffrey Chang, M.D.
Sub-Investigator: Marcus Rosencrantz, M.D.

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

R, Jeffrey Chang, M.D.

UCSD SChool of Medicine

More Information

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. 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.

Responsible Party:	University of California, San Diego-School of Medicine ( R. Jeffrey Chang, M.D. )
Study ID Numbers:	060679
Study First Received:	September 4, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00747617
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Diego:

polycystic ovary syndrome
androgens
ovary
LH

Study placed in the following topic categories:

Genital Diseases, Female
Gonadal Disorders
Polycystic Ovary Syndrome
Endocrine System Diseases
Endocrinopathy

Ovarian Diseases
Chorionic Gonadotropin
Cysts
Ovarian Cysts

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Therapeutic Uses
Syndrome

Physiological Effects of Drugs
Reproductive Control Agents
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009