Approved for the Prevention of PMO

Vivelle-Dot^® is FDA Approved for the Prevention of Postmenopausal Osteoporosis

Vivelle-Dot is effective in the prevention of postmenopausal osteoporosis (PMO) at any of its 5 prescribed dosage strengths (0.025 mg/day,* 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day). Vivelle-Dot 0.025 mg/day is indicated for the prevention of PMO only. When prescribing solely for the prevention of PMO, therapy should only be considered for women at significant risk of osteoporosis after non-estrogen medications have been carefully considered.

AP=anteroposterior.

*Vivelle-Dot 0.025 mg/day is indicated for the prevention of PMO only.

†In a pharmacokinetic study, Vivelle-Dot was shown to be bioequivalent to Vivelle. Vivelle is no longer commercially available.

Least squares means of percentage change from baseline. All randomized patients with at least 1 postbaseline assessment available with last postbaseline observation carried forward.

Results from a 2-year, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Vivelle in the prevention of PMO. 261 surgically or naturally postmenopausal women were randomized to apply the estradiol matrix transdermal system (0.025, 0.0375, 0.05, or 0.1 mg/day) or matching placebo twice a week for 2 years. Patients were given supplemental dietary calcium (1000 mg elemental calcium/day) but no supplemental vitamin D.