Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative
study (24-week treatment period).
The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended
regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of
primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation
period.
In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients
treated for one year will be investigated.