About this trial
The purpose of this study is to determine if estradiol augmentation of luteinizing hormone (LH) secretion secretion (primary endpoint) and follicle-stimulating hormone (FSH) secretion (secondary endpoint) is reduced in adult women with polycystic ovary syndrome.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
PCOS group: post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and/or laboratory evidence of hyperandrogenism (hirsutism and/or elevated serum [calculated] free testosterone concentration) plus ovulatory dysfunction (irregular menses, fewer than 9 per year), but without evidence for other potential causes of hyperandrogenism and/or ovulatory dysfunction
Control group: post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no evidence of hyperandrogenism (i.e., no hirsutism, normal serum [calculated] free testosterone concentration)
General good health (excepting overweight, obesity, PCOS, and adequately-treated hypothyroidism)
Capable of and willing to provide informed consent
Disqualifiers
Inability/incapacity to provide informed consent
Males will be excluded (hyperandrogenism is unique to females)
Age < 18 years (we do not propose to study children because we have no preliminary data that would support this particular study in children)
Age > 30 years (since ovarian reserve may decrease beyond age 30)
Trial design
Single group
Treatments tested in this trial
Estradiol
DrugSubjects will receive graded doses of transdermal estradiol patches for up to 7 days. Blood estradiol tests will be performed daily, and the number of estradiol patches used will be adjusted to maintain serum estradiol levels of 250-400 pg/ml. Estradiol is a natural hormone.
Treatment groups
Trial outcomes
Primary outcomes
Estradiol-induced change in 24-hour urinary LH excretion
The estradiol-induced change in 24-hour urinary LH excretion is defined as the 24-hour urinary LH excretion immediately prior to estradiol administration vs. the peak 24-hour urinary LH excretion during estradiol administration.
Secondary outcomes
Estradiol-induced change in 24-hour urinary FSH excretion
The estradiol-induced change in 24-hour urinary FSH excretion is defined as the 24-hour urinary FSH excretion immediately prior to estradiol administration vs. the peak 24-hour urinary FSH excretion during estradiol administration.
Sponsors and contacts
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