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Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome


N/A
18 Years
37 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information

Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

17-hydroxyprogesterone responses to hCG with and without FSH in PCOS women and normal controls

Outcome Time Frame:

up to 2 years

Safety Issue:

No

Principal Investigator

R. Jeffrey Chang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Professor

Authority:

United States: Food and Drug Administration

Study ID:

090560

NCT ID:

NCT00989781

Start Date:

September 2009

Completion Date:

September 2013

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS, Androgens, ovary, polycystic
  • Polycystic Ovary Syndrome

Name

Location

UCSD Medical CenterLa Jolla, California  92093