Jane S. Ricciuti, RPh, MS


July 13, 2004

In This Article


(estradiol) Transdermal System

Manufacturer: Berlex Labs

Drug Approval Classification: Original New Drug Application (Approval Date: 6/8/04)

Indication: Menostar (estradiol) Transdermal System is indicated for the prevention of postmenopausal osteoporosis. Therapy should be considered only for women at significant risk of osteoporosis. Non-estrogen medications should be carefully considered.

Dosing: Menostar should be applied once every 7 days. Menostar is designed to provide nominal in vivo delivery of 14 mcg 17-beta-estradiol per day continuously upon application to intact skin.

Clinical Summary: The Menostar labeling includes a black box warning consistent with other estrogen products that warns of the increased risk of endometrial cancer, cardiovascular related events, and the results of the Women's Health Initiative (WHI) study that reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens. The WHI reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo.

Adverse Effects: Adverse events related to Menostar were consistent with other estrogen products (see Clinical Summary and labeling for Black Box warning information).

Pharmacokinetics: The bioavailability of estradiol following application of a Menostar transdermal system, relative to that of a transdermal system delivering 25 mcg/day, was investigated in 18 healthy postmenopausal women who had a mean age of 66 years (range, 60-80 years). Transdermal administration produced geometric mean serum concentration (Cavg) of estradiol of 13.7 pg/mL. Following application of the transdermal system to the abdomen, it is estimated to provide an average nominal in vivo daily delivery of 14 mcg estradiol/day.


Menostar (estradiol) Transdermal System Labeling


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