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Safety and Tolerability
In the ULTRA trial, MENOSTAR® (estradiol transdermal system) was well tolerated with side effects comparable to placebo.1
The study demonstrated:
- No significant increase in endometrial hyperplasia (0% at year 1, 0.5% at year 2). No concomitant progestin used. A 14-day course of progestin is recommended every 6 to 12 months for women with a uterus. Endometrial sampling at yearly intervals or as clinically indicated is recommended
- No significant increase in bleeding vs placebo in the first year, nonstatistically significant increase at the end of the second year
The following is a summary of the most frequently reported side effects occurring ≥5% over 24 months in the ULTRA study2

*No reported increase in patient discomfort.
†Benign.
References:
1. Data on file. Montville, NJ: Bayer HealthCare Pharamceuticals, Inc; 2004.
2. MENOSTAR prescribing information. Montville, NJ: Bayer HealthCare Pharamceuticals, Inc; 2004.
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