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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jeffrey Chang, MD, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT00747617

First received: September 4, 2008

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 4, 2008

Last Updated Date

January 28, 2013

Start Date ^ICMJE

September 2007

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Serum 17OHP Responses to hCG [ Time Frame: 24 hrs post dose ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00747617 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Theca Cell Function in Women With Polycystic Ovary Syndrome

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Polycystic Ovary Syndrome

Intervention ^ICMJE

Drug: recombinant human chorionic gonadotropin

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

Other Name: Ovidrel

Study Arm (s)

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

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

Intervention: Drug: recombinant human chorionic gonadotropin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00747617

Other Study ID Numbers ^ICMJE

060679

Has Data Monitoring Committee

Yes

Responsible Party

Jeffrey Chang, MD, University of California, San Diego

Study Sponsor ^ICMJE

University of California, San Diego

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

R, Jeffrey Chang, M.D.

UCSD SChool of Medicine

Information Provided By

University of California, San Diego

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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