In the placebo-controlled clinical trials, the prasterone treated group had a significantly lower incidence of breast cancer than the placebo group. Among subjects at least 45 years of age, incidence of breast cancer in the placebo group was 4.2%, and 1.5% in prasterone-treated group (p = 0.018). Expressed as a rate per patient-year of observation for patients >45 years of age, these rates are 4.6/1000 for prasterone and 6.5/1000 for placebo. However, it would appear prudent for post-menopausal patients receiving Prastera® to follow current mammography guidelines.
In the Phase 3 clinical trials, the treatment and placebo groups showed no difference in meno-metrorrhagia or vaginal bleeding, and post-menopausal patients showed no difference in endometrial hyperplasia (as measured by uterine ultrasound screening and uterine biopsies).
