Effect of High Testosterone on Sleep-associated Slowing of Follicular Luteinizing Hormone (LH) Fr… (NCT00930228) | Clinical Trial Compass
UnknownPhase 1
Effect of High Testosterone on Sleep-associated Slowing of Follicular Luteinizing Hormone (LH) Frequency in Polycystic Ovary Syndrome
United States72 participantsStarted 2009-01
Plain-language summary
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.
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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Inclusion Criteria:
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.).
Exclusion Criteria:
* 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.
* Virilization.
* 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 ac…