check_circleStudy Completed
Dysmenorrhea
Bayer Identifier:
16114
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Comparative study of BAY86-5300 with a flexible extended regimen for dysmenorrhea
Trial purpose
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.
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.
Key Participants Requirements
Sex
FemaleAge
20 - N/ATrial summary
Enrollment Goal
216Trial Dates
July 2013 - August 2015Phase
Phase 3Could I Receive a placebo
NoProducts
EE20/DRSP (BAY86-5300)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Suginami-ku, 167-0051, Japan | |
Completed | Toshima-ku, 171-0021, Japan | |
Completed | Setagaya-ku, 157-0066, Japan | |
Completed | Osaka, 542-0086, Japan | |
Completed | Hachioji, 192-0046, Japan | |
Completed | Minato, 108-0071, Japan | |
Completed | Matsudo, 270-2267, Japan | |
Completed | Osaka, 530-0013, Japan |
Primary Outcome
- Number of days with dysmenorrheic pain over 140 days of evaluation periodNumber of days with dysmenorrheic pain is determined based on daily record of Patient Diary.date_rangeTime Frame:Evaluation period which starts on 25th day after start of treatment and lasts for 140 daysenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in Dysmenorrhea score from baseline to period of withdrawal bleedingDysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visitdate_rangeTime 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 daysenhanced_encryptionNoSafety Issue:
- Change of severity of pain DescriptionThe severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit.date_rangeTime 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 daysenhanced_encryptionNoSafety Issue:
- Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation periodNumber of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary.date_rangeTime Frame:Evaluation period which starts on 25th day after start of treatment and lasts for 140 daysenhanced_encryptionNoSafety Issue:
- Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation periodNumber of days with rescue medicine is determined based on daily record of Patient Diary.date_rangeTime Frame:Evaluation period which starts on 25th day after start of treatment and lasts for 140 daysenhanced_encryptionNoSafety Issue:
- Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation periodNumber of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diarydate_rangeTime Frame:Evaluation period which starts on 25th day after start of treatment and lasts for 140 daysenhanced_encryptionNoSafety Issue:
- Endometrial thicknessEndometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.date_rangeTime Frame:24 weeks after taking the initial study medicationenhanced_encryptionNoSafety Issue:
- Number of days with bleeding and spotting over treatment phaseNumber of days with spotting/bleeding is determined based on daily record of Patient Diary.date_rangeTime Frame:Up to 24 weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2