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

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.

Timeline

Start

2013-07

Primary completion

2015-01

Completion

2015-08

Publications

• Momoeda M, Akiyama S, Yamamoto S, Kondo M, Fukai T. Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study. Int J Womens Health. 2020 Mar 10;12:175-185. doi: 10.2147/IJWH.S242864. eCollection 2020.

Drugs

Indications