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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Number of days with dysmenorrheic pain over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]

Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Dysmenorrhea score from baseline to period of withdrawal bleeding [ Time Frame: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    Dysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visit
  • Change of severity of pain Description [ Time Frame: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    The severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit.
  • Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    Number of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary.
  • Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    Number of days with rescue medicine is determined based on daily record of Patient Diary.
  • Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary
  • Endometrial thickness [ Time Frame: 24 weeks after taking the initial study medication ]
    Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
  • Number of days with bleeding and spotting over treatment phase [ Time Frame: Up to 24 weeks ]
    Number of days with spotting/bleeding is determined based on daily record of Patient Diary.


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: July 2, 2013
Date Started: July 2013
Date Completion:
Last Updated: September 8, 2015
Last Verified: September 2015