The purpose of this study is to determine whether a testosterone receptor blocker (flutamide)
will normalize sleep-wake luteinizing hormone pulse frequency relationships in women with
polycystic ovary syndrome.
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Locations near you
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Full eligibility criteria for NCT00930228
Ages eligible for Study
18 Years to 35 Years
Genders eligible for Study
Accepts Healthy Volunteers
Inclusion criteria for all participants:
Subjects will be 18-35 years old; we use a cutoff age of 35 y because early menopause at this age is very rare.
No significant health problems (other than PCOS and obesity).
Subjects will be willing to strictly avoid pregnancy (using non-hormonal methods) during the time of study and must be willing and able to provide informed consent. Inclusion criteria for normal controls:
Controls will be healthy women with regular menstrual cycles and no evidence of hyperandrogenism. Inclusion criteria for PCOS:
PCOS will be defined according to NIH consensus criteria.
As such, subjects with PCOS will have hyperandrogenism, whether it is clinical
(e.g., hirsutism) or biochemical (i.e., elevated plasma T).
Subjects with PCOS will also have oligo- or amenorrhea (i.e., < 7 periods per year) and no evidence for other endocrinopathies (e.g., hyperprolactinemia, Cushing's syndrome, etc.).
Being a study of GnRH pulse regulation in women with and without PCOS, men are excluded.
Obesity associated with a diagnosed (genetic) syndrome, obesity related to medications
(e.g., glucocorticoids), etc.
Pregnancy or lactation.
A total testosterone > 150 ng/dl in women with PCOS (which suggests the possibility of a virilizing neoplasm) (confirmed on repeat).
Elevated DHEAS (mild elevations may be seen in PCOS, and elevations < 1.5 times the upper limit of normal will be accepted in PCOS)(confirmed on repeat).
Follicular 17-hydroxyprogesterone > 300 ng/dl, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase and there is a concern about the possibility of congenital adrenal hyperplasia, the 17-hydroxyprogesterone may be collected during the follicular phase, or >60 if oligomenorrheic).
*NOTE: If a 17-hydroxyprogesterone > 300 ng/dl is confirmed on such repeat testing, an ACTH stimulated 17-hydroxyprogesterone < 1000 ng/dl will be required for study participation.
A previous diagnosis of diabetes, a fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c > 6.5%
Abnormal TSH (subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded; or, for a new diagnosis of hypothyroidism, further study will at the least be delayed pending appropriate treatment) (confirmed on repeat).
Abnormal prolactin (mild elevations may be seen in PCOS, and elevations < 1.5 times the upper limit of normal will be accepted in this group) (confirmed on repeat).
Evidence of Cushing's syndrome by history or physical exam.
Hematocrit < 36% or hemoglobin < 12 g/dl (that is not reversed by iron treatment).
Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
Liver test abnormalities (confirmed on repeat), with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome.
Abnormal sodium or potassium (confirmed on repeat); bicarbonate concentration <20 or
>30 (confirmed on repeat); or elevated creatinine concentration (confirmed on repeat).
Due to the amount of blood being drawn in the study, subjects with body weight < 110 lbs will be excluded from the study.
All locations for NCT00930228
United States (1)
University of Virginia
Charlottesville, Virginia, United States, 22908
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View full eligibility
Tris trial is registered with FDA with number: NCT00930228. The sponsor of the trial is University of Virginia and it is looking for 72 volunteers for the current phase.
Official trial title: Influence of Hyperandrogenemia on the Sleep-associated Slowing of Follicular LH Frequency in Adult Polycystic Ovary Syndrome
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