ACTIVELLA®—Prescription hormone therapy with an estrogen just like your own. Now you can replace what your body is missing with what you want in a hormone therapy.
Prevention of postmenopausal osteoporosis in women
The results of two randomized, multicenter, calcium-supplemented (500-1000 mg/day), placebo-controlled, 2 year clinical trials have shown that ACTIVELLA® 1.0 mg/0.5 mg and estradiol 0.5 mg are effective in preventing bone loss in postmenopausal women.1
US=United States, EU=European
†While ACTIVELLA® 0.5 mg/0.1 mg was not directly studied in these trials, the US trial showed that addition of NETA to estradiol enhances the effect on BMD, therefore the BMD changes expected from treatment with ACTIVELLA® 0.5 mg/0.1 mg should be at least as great as observed with estradiol 0.5 mg.
* Significantly (p<0.001) different from placebo
** Significantly (p<0.007) different from placebo
*** Significantly (p<0.002) different from placebo
The overall difference in mean percentage change in BMD at the lumbar spine in the US trial (1000 mg/day calcium) between ACTIVELLA® 1.0 mg/0.5 mg and placebo was 5.9% and between estradiol 0.5 mg and placebo was 4.4%. In the European trial (500 mg/day calcium), the overall difference in mean percentage change in BMD at the lumbar spine was 6.3%. ACTIVELLA® 1.0 mg/0.5 mg and estradiol 0.5 mg also increased BMD at the femoral neck and femoral trochanter compared to placebo.1
A total of 462 postmenopausal women with intact uteri and baseline BMD values for lumbar spine within 2 standard deviations of the mean in healthy young women were enrolled. In a US trial, 327 postmenopausal women (mean time from menopause 2.5 to 3.1 years) with a mean age of 53 years were randomized to 7 groups (0.25 mg, 0.5 mg, and 1 mg of estradiol alone, 1 mg estradiol with 0.25 mg norethindrone acetate, 1 mg estradiol with 0.5 mg norethindrone acetate, and 2 mg estradiol with 1 mg norethindrone acetate, and placebo.) In a European trial (EU trial), 135 postmenopausal women (mean time from menopause 8.4 to 9.3 years) with a mean age of 58 years were randomized to 1 mg estradiol with 0.25 mg norethindrone acetate, 1 mg estradiol with 0.5 mg norethindrone acetate, and placebo. Approximately 58% and 67% of the randomized subjects in the two clinical trials, respectively, completed the two clinical trials. BMD was measured using dual-energy x-ray absorptiometry (DEXA).1
