Back to resultsComparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
EE20/DRSP(BAY86-5300)
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea focused on measuring YAZ, Flexible regimen, Drospirenone, Ethinylestradiol Betadex, Dysmenorrhea, Japanese patients
Eligibility Criteria
Inclusion Criteria: - Dysmenorrhea patients with a total dysmenorrhea score (sum of the two sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of the last two menstruations before randomization (baseline observation phase)
- Patients with dysmenorrheic pain during the 2 baseline cycles before randomization. Dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with possible radiation towards back or thighs recorded in the Patient Diary in correspondence with a withdrawal and/or menstrual bleeding episode. Pain could start up to 2 days before the onset of the bleeding episode the bleeding and terminates on the last day of bleeding of before
- Patients having the regular cyclic menstrual period (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
- Willingness to use a barrier method (i.e., non-hormonal method) for contraception during the study. Acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device.
Exclusion Criteria: - Patients who have organic diseases of which surgical treatment is prioritized by the investigator
- Patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in size of the longest diameters
- Patients with ovarian chocolate cysts having solid part in the cyst
- Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EE20/DRSP(BAY86-5300)-flexibel extended regimen
EE20/DRSP(BAY86-5300)-28 days cyclic regimen
Arm Description
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with flexible extended regimen (24-day to 120-day active tablet intake followed by 4-day tablet free interval)
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with 28-day cyclic regimen (24-day active tablet intake followed by 4-day placebo tablet intake)
Outcomes
Primary Outcome Measures
Number of days with dysmenorrheic pain over 140 days of evaluation period
Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.
Secondary Outcome Measures
Change in Dysmenorrhea score from baseline to period of withdrawal bleeding
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
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
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
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
Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary
Endometrial thickness
Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
Number of days with bleeding and spotting over treatment phase
Number of days with spotting/bleeding is determined based on daily record of Patient Diary.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01892904
Brief Title
Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
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-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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
YAZ, Flexible regimen, Drospirenone, Ethinylestradiol Betadex, Dysmenorrhea, Japanese patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EE20/DRSP(BAY86-5300)-flexibel extended regimen
Arm Type
Experimental
Arm Description
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with flexible extended regimen (24-day to 120-day active tablet intake followed by 4-day tablet free interval)
Arm Title
EE20/DRSP(BAY86-5300)-28 days cyclic regimen
Arm Type
Active Comparator
Arm Description
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with 28-day cyclic regimen (24-day active tablet intake followed by 4-day placebo tablet intake)
Intervention Type
Drug
Intervention Name(s)
EE20/DRSP(BAY86-5300)
Intervention Description
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
Primary Outcome Measure Information:
Title
Number of days with dysmenorrheic pain over 140 days of evaluation period
Description
Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.
Time Frame
Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Secondary Outcome Measure Information:
Title
Change in Dysmenorrhea score from baseline to period of withdrawal bleeding
Description
Dysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visit
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
Title
Change of severity of pain Description
Description
The severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit.
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
Title
Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period
Description
Number of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary.
Time Frame
Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Title
Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period
Description
Number of days with rescue medicine is determined based on daily record of Patient Diary.
Time Frame
Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Title
Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period
Description
Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary
Time Frame
Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Title
Endometrial thickness
Description
Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
Time Frame
24 weeks after taking the initial study medication
Title
Number of days with bleeding and spotting over treatment phase
Description
Number of days with spotting/bleeding is determined based on daily record of Patient Diary.
Time Frame
Up to 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Dysmenorrhea patients with a total dysmenorrhea score (sum of the two sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of the last two menstruations before randomization (baseline observation phase)
Patients with dysmenorrheic pain during the 2 baseline cycles before randomization. Dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with possible radiation towards back or thighs recorded in the Patient Diary in correspondence with a withdrawal and/or menstrual bleeding episode. Pain could start up to 2 days before the onset of the bleeding episode the bleeding and terminates on the last day of bleeding of before
Patients having the regular cyclic menstrual period (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
Willingness to use a barrier method (i.e., non-hormonal method) for contraception during the study. Acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device.
Exclusion Criteria: - Patients who have organic diseases of which surgical treatment is prioritized by the investigator
Patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in size of the longest diameters
Patients with ovarian chocolate cysts having solid part in the cyst
Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
270-2267
Country
Japan
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0046
Country
Japan
City
Minato
State/Province
Tokyo
ZIP/Postal Code
108-0071
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-0066
Country
Japan
City
Suginami-ku
State/Province
Tokyo
ZIP/Postal Code
167-0051
Country
Japan
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan
City
Osaka
ZIP/Postal Code
530-0013
Country
Japan
City
Osaka
ZIP/Postal Code
542-0086
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32210639
Citation
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.
Results Reference
derived
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Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
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