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.