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Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Variability of serum estrogens among postmenopausal women treated with the same transdermal estrogen therapy and the effect on androgens and sex hormone binding globulin.
Fertility and Sterility 2003 March
OBJECTIVE: To examine the variability of serum estrogens in response to transdermal estrogen replacement therapy (ET), and to determine the effects on androgens and sex hormone binding globulin (SHBG).
DESIGN: Randomized, double-blind, placebo-controlled study.
SETTING: Women's hospital.
PATIENT(S): Two groups of postmenopausal women: [1] 21 women not on ET enrolled and 17 completed the study; [2] 19 women on continuous transdermal ET enrolled and 13 completed the study.
INTERVENTION(S): Women not on ET were administered a placebo patch or a newly initiated estrogen patch, then crossed over to the alternate treatment. Serum samples were obtained at baseline and the subsequent 3 days from the placebo and new-patch groups and from a separate group of women receiving continuous estrogen patch treatment.
MAIN OUTCOME MEASURE(S): Estradiol (E(2)), estrone, estrone sulfate, T, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), androstenedione, free androgen index, and SHBG.
RESULT(S): There was considerable intrapatient and interpatient variability in the estrogen response to identical treatment doses, with E(2) values differing between women as much as 138 pg/mL and E(2) increases above baseline differing as much as 90 pg/mL. Continuous treatment increased SHBG and decreased androstenedione levels; however, levels of T, DHEA, DHEAS, and free androgen index did not change.
CONCLUSION(S): There is great variability of estrogen in response to transdermal ET, but minimal effect on circulating androgens.
DESIGN: Randomized, double-blind, placebo-controlled study.
SETTING: Women's hospital.
PATIENT(S): Two groups of postmenopausal women: [1] 21 women not on ET enrolled and 17 completed the study; [2] 19 women on continuous transdermal ET enrolled and 13 completed the study.
INTERVENTION(S): Women not on ET were administered a placebo patch or a newly initiated estrogen patch, then crossed over to the alternate treatment. Serum samples were obtained at baseline and the subsequent 3 days from the placebo and new-patch groups and from a separate group of women receiving continuous estrogen patch treatment.
MAIN OUTCOME MEASURE(S): Estradiol (E(2)), estrone, estrone sulfate, T, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), androstenedione, free androgen index, and SHBG.
RESULT(S): There was considerable intrapatient and interpatient variability in the estrogen response to identical treatment doses, with E(2) values differing between women as much as 138 pg/mL and E(2) increases above baseline differing as much as 90 pg/mL. Continuous treatment increased SHBG and decreased androstenedione levels; however, levels of T, DHEA, DHEAS, and free androgen index did not change.
CONCLUSION(S): There is great variability of estrogen in response to transdermal ET, but minimal effect on circulating androgens.
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