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NCT Number: NCT00747617

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of California, San Diego, School of Medicine

La Jolla, California, 92093, United States

About this study

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 The total amount of blood withdrawn will be about 35 teaspoons.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant human chorionic gonadotropin

Drug

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

Other names: Ovidrel

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Theca Cell Function in Women With Polycystic Ovary Syndrome

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 5, 2008
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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