How Vivelle-Dot^® Works

Estrogen Delivery

Even though the patch is tiny, Vivelle-Dot provides continuous, sustained release of estradiol directly into the bloodstream over 3 ½ days.

Clinical Study: Effect on Vasomotor Symptoms

In a pharmacokinetic study, Vivelle-Dot was shown to be bioequivalent to Vivelle^®. In two controlled clinical trials with Vivelle, of 356 subjects, the 0.075 and 0.1 mg doses were superior to placebo in relieving vasomotor symptoms at Week 4, and maintained efficacy through Week 8 and 12 of treatment. In this original study, the 0.0375 and 0.05 mg doses, however, did not differ from placebo until approximately Week 6, therefore, an additional 12-week placebo-controlled study in 255 patients was performed with Vivelle to establish the efficacy of the lowest dose of 0.0375 mg. The baseline mean daily number of hot flashes in these 255 patients was 11.5. Results at Week 4, 8, and 12 of treatment are shown in the figure below. (See Figure 1)

Figure 1

The 0.0375 mg dose was superior to placebo in reducing both the frequency and severity of vasomotor symptoms at Week 4 and maintained efficacy through Weeks 8 and 12 of treatment. All doses of Vivelle (0.0375 mg, 0.05 mg, 0.075 mg, and 0.1 mg) are effective for the control of vasomotor symptoms.

The efficacy and safety of Vivelle-Dot has also been studied in the prevention of postmenopausal osteoporosis.

Dosage

Vivelle-Dot delivers flexibility with five dosage strengths to meet individual patient needs. Your patient will change her patch twice a week. Dosage strengths are: