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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
  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.


Condition Intervention Phase
Polycystic Ovary Syndrome
 Drug: recombinant human chorionic gonadotropin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Theca Cell Function in Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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


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

Enrollment: 25
Study Start Date: September 2007
Study Completion Date: September 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

Locations
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
Principal Investigator: R, Jeffrey Chang, M.D. UCSD SChool of Medicine
  More Information

Publications:

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

Responsible Party: Jeffrey Chang, MD, Principal investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00747617     History of Changes
Other Study ID Numbers: 060679
Study First Received: September 4, 2008
Results First Received: August 4, 2011
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
polycystic ovary syndrome
androgens
ovary
LH

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013