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

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ClinicalTrials.gov Identifier: NCT00747617
Recruitment Status : Completed
First Posted : September 5, 2008
Results First Posted : January 29, 2013
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey Chang, MD, University of California, San Diego

Study Description
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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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: recombinant human chorionic gonadotropin Phase 3

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, 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 The total amount of blood withdrawn will be about 35 teaspoons.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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Theca Cell Function in Women With Polycystic Ovary Syndrome
Study Start Date : September 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Serum 17OHP Responses to hCG [ Time Frame: 24 hrs post dose ]
    Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects


Secondary Outcome Measures :
  1. Serum Testosterone Responses to hCG [ Time Frame: -0.5, 0, 24 hrs ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747617


Locations
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United States, California
University of California, San Diego, School of Medicine
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: R, Jeffrey Chang, M.D. UCSD SChool of Medicine
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeffrey Chang, MD, Principal investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00747617    
Other Study ID Numbers: 060679
First Posted: September 5, 2008    Key Record Dates
Results First Posted: January 29, 2013
Last Update Posted: November 21, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeffrey Chang, MD, University of California, San Diego:
polycystic ovary syndrome
androgens
ovary
LH
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
 Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs