The findings further demonstrate the therapeutic potential of Visanne and are expected to support a marketing authorization application with the China Food and Drug Administration (CFDA).
The trial’s results were reported in the study titled, “Dienogest for Treatment of Endometriosis in Chinese Women:A Placebo-Controlled, Randomized, Double-Blind Phase 3 Study,” which appeared in the Journal Of Women’s Health.
Visanne is a synthetic hormone that combines the beneficial effects of progesterone with the suppressive effects of estrogen. Its unique mode of action has the potential to reduce endometrium tissue growth while preventing inflammation, cell proliferation, and blood vessel formation.
Previous research has shown that Visanne can provide pain relief similar to Lupron (leuprolide acetate) and Etilamide (buserelin), but without some of their side effects.
Other studies have shown that administration of 2 mg daily of Visanne was safe and effectively prevented pain symptoms in women with endometriosis. More recently, results of the VISADO Phase 2 trial (NCT01283724) showed that daily treatment with this synthetic hormone is safe and effective for the long-term treatment of adolescents with endometriosis.
In order to confirm these effects in another population, researchers conducted the Phase 3 study (NCT01822080) in 23 clinical sites in China, with 255 adult women diagnosed with endometriosis and who had endometriosis-associated pelvic pain. The patients were randomly designated to receive 2 mg of Visanne or a placebo daily for up to 24 weeks.
The researchers reported that treatment with Visanne reduced the pelvic pain score by 67% from baseline compared with a 26% reduction in the placebo group. Treated patients also reported improvements in their overall quality of life.
After 24 weeks of treatment, no significant changes in bone mineral density were reported in the treated group. Visanne treatment was associated with mild adverse effects, the most common being vaginal hemorrhage.
Visanne “2mg once daily for 24 weeks was superior to placebo in reducing EAPP and was safe and well tolerated in Chinese women with endometriosis,” the researchers concluded in the report. “The results are consistent with studies previously conducted in European women.”
The patients who participated in this study had the opportunity to continue treatment with Visanne for up to an additional 28 weeks. Data from this trial extension will provide long-term safety and efficacy information on Visanne in Chinese women with endometriosis.
This clinical trial was supported by Bayer AG.