Last updated on February 2018

Investigation of Estradiol-induced Gonadotropin Surge Generation in PCOS

Brief description of study

The purpose of this study is to learn how a hormone called estradiol (estrogen) affects the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) in women with polycystic ovary syndrome (PCOS). The study will assess whether estradiol-induced LH and FSH release is impaired in women with PCOS.

Detailed Study Description

LH and FSH are hormones made by the pituitary gland. The pituitary is a small gland located below the brain. LH and FSH control the ovaries, including ovarian follicle (egg) development and ovarian hormone production. Estradiol is a hormone that mostly comes from the ovaries. In particular, as an ovarian follicle (egg) develops and grows, it makes more and more estradiol. Ovulation is the release of an egg from the ovary. Ovulation happens after estradiol, and then LH and FSH, rise to high levels. Specifically, high estradiol levels cause the pituitary gland to produce high LH and FSH levels, and these high LH and FSH levels cause ovulation. Women are normally expected to ovulate with most menstrual cycles.

PCOS is a hormonal disorder common among women of reproductive age. Women with PCOS may have infrequent or prolonged menstrual periods or excess male hormone (androgen) levels. Women with PCOS may ovulate irregularly (or not at all), which can make it difficult to become pregnant.

During this study, researchers hope to learn how women with and without PCOS may respond differently to estradiol. The investigators think that, in women with PCOS, LH and FSH levels may not increase normally when estradiol levels are high, so their LH and FSH levels may not be high enough to cause ovulation effectively. This study will be done by measuring LH and FSH in urine and blood specimens while women wear skin patches that deliver estradiol to the woman's body.

During this study, women will have estradiol skin patches placed on their abdomen every morning in the University of Virginia (UVa) Clinical Research Unit. This form of estrogen is 17-beta estradiol, which is identical to the main estrogen hormone that the body produces. The dose of the estradiol will be gradually increased in the study, because in the normal menstrual cycle, the body's estradiol level gradually increases to cause ovulation. This method of estradiol administration is expected keep hormone levels within the normal range that would be seen during a normal menstrual cycle.

Clinical Study Identifier: NCT03401047

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Christopher R McCartney, M.D.

University of Virginia Clinical Research Unit
Charlottesville, VA United States
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