Dysmenorrhea Clinical Trial
Official title:
A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of a Flexible Extended Regimen of BAY 86-5300 (0.02 mg Ethinylestradiol [β-CDC] and 3 mg Drospirenone) Compared to the 28-day (24 + 4-day) Regimen of BAY 86-5300 in the Treatment of Dysmenorrhea for 24 Weeks
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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