Expired Study
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La Jolla, California 92093


Purpose:

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.


Study summary:

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 The total amount of blood withdrawn will be about 35 teaspoons.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


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


Study is Available At:


Original ID:

060679


NCT ID:

NCT00747617


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Theca Cell Function in Women With Polycystic Ovary Syndrome


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Diego


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:R, Jeffrey Chang, M.D.
Principal Investigator
UCSD SChool of Medicine

Study Dates

Start Date:September 2007
Completion Date:September 2010
Completion Type:Actual
Primary Completion Date:April 2010
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:October 25, 2018
First Received Date:September 4, 2008
First Results Date:August 4, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Serum Testosterone Responses to hCG
Time Frame:-0.5, 0, 24 hrs
Safety Issues:False
Description:Mean serum testosterone levels before and after hCG injection. Serum testosterone levels before (-0.5 and 0 hrs) were averaged to achieve a single value
Outcome Type:Primary Outcome
Measure:Serum 17OHP Responses to hCG
Time Frame:24 hrs post dose
Safety Issues:False
Description:Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects

Study Interventions

Intervention Type:Drug
Name:recombinant human chorionic gonadotropin
Description:Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.
Arm Name:PCOS group
Other Name:Ovidrel

Study Arms

Study Arm Type:Active Comparator
Arm Name:Control 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.
Study Arm Type:Active Comparator
Arm Name:PCOS 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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Diego

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Chang RJ. The reproductive phenotype in polycystic ovary syndrome. Nat Clin Pract Endocrinol Metab. 2007 Oct;3(10):688-95. Review.
PMID:17893687
Reference Type:Reference
Citation: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.
PMID:18285408
Reference Type:Reference
Citation: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.
PMID:16720653
Reference Type:Reference
Citation: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.
PMID:16804036
Reference Type:Reference
Citation: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.
PMID:15644405
Reference Type:Reference
Citation:Chang RJ. A practical approach to the diagnosis of polycystic ovary syndrome. Am J Obstet Gynecol. 2004 Sep;191(3):713-7. Review.
PMID:15467530

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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