Allergan and Gedeon Richter announced positive results from the second Phase 3 trial of ulipristal acetate, evaluating its efficacy and safety for the treatment of abnormal bleeding due to uterine fibroids in women.
The second study, Venus II, was a multicenter, randomized, double-blind, placebo-controlled clinical trial in 432 premenopausal women aged 18–50 years with cyclic (22–35 days) abnormal uterine bleeding in ≥4 of the last 6 menstrual cycles, menstrual blood loss ≥80mL, ≥1 discrete uterine fibroid, follicle-stimulating hormone ≤20 mIU/mL, and uterine volume ≤20 weeks.
Patients received either 5mg or 10mg of ulipristal acetate or placebo for two separate 12-week treatment courses followed by a 12-week treatment-free follow-up period. The co-primary endpoints were percentage of patients with absence of uterine bleeding and time to absence of bleeding on treatment during Treatment Course One. Secondary endpoints include percentage of patients with absence of uterine bleeding from Day 11 to end of the first treatment course, percentage of patients with absence of bleeding after the second treatment course, time to absence of bleeding on treatment during treatment course two, and the change from baseline in the UFS-QOL revised Activities subscale at the end of the first treatment course.
Results from the study showed that treatment with ulipristal 5mg or 10mg doses achieved statistically significant outcomes over placebo (p<0.0001), meeting all the primary and secondary endpoints. Significantly more patients in the 10mg arm (54.8%) and the 5mg arm (42%) achieved absence of uterine bleeding compared to placebo (0%). Additionally, more patients treated with ulipristal 10mg (55.4%) and 5mg (34.6%) achieved absence of bleeding within 10 days after treatment initiation in Treatment Course One vs. placebo (0%). The most common adverse events for ulipristal acetate were hot flush, headache, fatigue, and nausea.
Ulipristal acetate is a selective progesterone receptor modulator (SPRM) which acts directly on the progesterone receptors in the endometrium, uterine fibroids, and the pituitary gland.
For more information visit Allergan.com or Richter.hu.