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Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea

Bayer · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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dysmenorrhea
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.
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