Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Jeffrey Chang MD is conducting a research study to learn more about the increased male
      hormone levels, otherwise known as androgens, seen in women with polycystic ovary syndrome
      (PCOS). Women with PCOS have ovaries that are comprised of many cysts, or follicles. They
      also have irregular or absent menstrual periods and symptoms of increased male hormones, such
      as facial hair or acne. In each part of the study (except part 4 which is for PCOS women
      only) we will be comparing responses of PCOS women to normal controls
    

Detailed description: 
      The first part of this study looks specifically at the structure of the ovaries, which are
      the female sex glands where both androgens and estrogens (female hormones) are made. It
      involves imaging your ovaries with a technology called 3-D Ultrasound. We are interested in
      recording the number, size and arrangement of the follicles in your ovaries.

      The second part of the study looks at how the ovary produces male hormones, or androgens,
      with and without follicle stimulating hormone (FSH) stimulation. Hormones are substances made
      by a gland in one part of the body which regulate another part. FSH is a hormone naturally
      produced by the pituitary gland located in the brain and it helps the ovary produce
      estrogens, or female hormones. LH is a hormone also naturally produced by the pituitary gland
      and it has the ability to stimulate the ovary to make androgens. We are interested to see how
      much androgen your ovaries will produce in response to LH with and without FSH. To accomplish
      this, you will be given FSH as well as hCG, a drug that acts like LH to stimulate the ovary;
      FSH and hCG are approved by the Food and Drug Administration (FDA) for this investigational,
      off-label use.

      The third part of the study looks at how much the adrenal glands contribute to the increase
      male hormone levels seen in PCOS. ACTH is a hormone naturally produced by the pituitary gland
      located in the brain and it stimulates the adrenals to make hormones. The adrenal glands are
      above the kidneys. They are chiefly responsible for helping the body adjust to stressful
      situations and work by producing cortisol and adrenaline. The adrenal glands also produce
      androgens, or male hormones. Previous studies have shown that some women with PCOS produce
      more male hormones from their adrenals. We are interested to see how much androgen your
      adrenal glands produce. To accomplish this, you will first be given dexamethasone, a stress
      steroid, to temporarily suppress your adrenal glands. You will then be given ACTH
      intravenously over the course of 7 hours to stimulate your adrenal glands.

      The fourth part of the study is for PCOS women only and looks at how much the role of insulin
      contributes to the increase male hormone levels. Insulin is a hormone naturally produced by
      the pancreas that stimulates all of the cells in your body to take up glucose, or sugar, from
      the blood. Previous studies have shown that PCOS women who are more resistant to insulin, or
      whose cells do not take up glucose from the blood in response to insulin, make more male
      hormones. We are interested to see how much androgen your ovaries produce in response to LH
      before and after we temporarily decrease the amount of insulin in your blood. To accomplish
      this, you will again be given hCG, a drug that acts like LH to stimulate the ovary, with and
      without diazoxide, a drug that decreases the amount of insulin in your bloodstream. These
      tests will all be done after you are on a diet that limits how much sugar you eat. To test
      how much insulin you make, you will also be given Oral Glucose Tolerance Tests before and
      after diazoxide. This test is done by drinking a sugary liquid and testing your blood over 3
      hours.
    

Intervention name(s): 3-D Ultrasound; recombinant human chorionic gonadotropin; Recombinant human follicle stimulating hormone; Adrenocorticotropin; Dexamethasone; Glucose
Intervention type(s): Radiation; Drug; Drug; Drug; Drug; Drug
Intervention description(s): One time pelvic ultrasound; Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards; Recombinant human follicle stimulating hormone will be given iv and blood samples obtained before and 24 hr later.; Each subject will receive a 7 hr dose-response infusion of Adrenocorticotropin.; Dexamethasone will be given prior to ACTH infusion test.; Each subject will undergo 3 oral glcuose tolerance tests.
Other intervention name(s): Ovidrel; r-hCG; Gonal-F; r-hFSH; Cosyntropin; ACTH; corticosteroid; sugar
Intervention MeSH terms: Dexamethasone; Chorionic Gonadotropin; Hormones; Follicle Stimulating Hormone; Cosyntropin; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: PCOS, Androgens, ovary, polycystic