Endometriosis Clinical Trial
Official title:
A Multi-center, Randomized, Double-blinded, Placebo-controlled, and Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of an Extended Flexible Regimen of BAY 86-5300 [0.02 mg Ethinylestradiol (β-CDC) and 3 mg Drospirenone] in the Patients With Endometriosis
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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