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How Vivelle-Dot® Works |
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Estrogen Delivery
Even though the patch is tiny, Vivelle-Dot provides controlled,
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® (estradiol transdermal system). In two controlled clinical trials with Vivelle-Dot, 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 Weeks 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-Dot 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 Weeks 4, 8,
and 12 of treatment are shown in the figure below.(See Figure 2.)
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:
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0.025 mg/day
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0.0375 mg/day
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0.05 mg/day
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0.075 mg/day
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0.1 mg/day
Vivelle-Dot 0.025 mg/day is indicated for prevention of postmenopausal
osteoporosis only.
See full prescribing information PDF.
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