Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study
(24-week treatment-comparison phase) with an open-label reference arm of active comparator
(dienogest) followed by 28-week long-term treatment phase.
The primary objective of this study is to confirm the superiority of BAY86-5300 when
administered with an extended flexible regimen for the treatment of endometriosis-associated
pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.
The secondary objective is to investigate the long-term safety of BAY86-5300 in patients
treated with an extended flexible regimen for one year, and the bleeding pattern of
BAY86-5300 when administered with an extended flexible regimen compared to dienogest.