Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 37 |
| Updated: | 6/6/2018 |
| Start Date: | September 2009 |
| End Date: | September 2013 |
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
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
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.
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.
Inclusion Criteria:
A group of 40 women with PCOS and 20 normal women ages 18-37 will be studied.
- Subjects will be determined to have PCOS based on clinical history of irregular menses
and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on
ultrasound.
- Subjects should not have been on any hormonal therapy or metformin for at least 2
months prior to study start.
- Subjects will be determined to be normal controls if they have a clinical history of
regular periods
Exclusion Criteria:
- Women with hemoglobin less than 11 gm/dl at screening evaluation
- Women with untreated thyroid abnormalities
- Pregnant women or women who are nursing
- Women with BMI > 37
- Women with known sensitivity to the agents being used
- Women with prosthetic devices (i.e.,ear)/ shunts (ventricular), Hearing aids, Metal
plate/pins/screws/wires
- Women with diabetes, or renal, liver, or heart disease.
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