NCT01892904

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	EE20/DRSP(BAY86-5300)	One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-01-01
• Completion: 2015-08-01
• First posted: 2013-07-08
• Last updated: 2015-09-09

Locations

8 sites across 1 country: Japan