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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EE20/DRSP(BAY86-5300)-flexibel extended regimen | Experimental | One tablet [0.02 mg of ethinylestradiol (ÎČ-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) |
|
| EE20/DRSP(BAY86-5300)-28 days cyclic regimen | Active Comparator | One tablet [0.02 mg of ethinylestradiol (ÎČ-CDC) and 3 mg of drospirenone] / day with 28-day cyclic regimen (24-day active tablet intake followed by 4-day placebo tablet intake) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE20/DRSP(BAY86-5300) | Drug | One tablet [0.02 mg of ethinylestradiol (ÎČ-CDC) and 3 mg of drospirenone] / day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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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)
Exclusion Criteria: - Patients who have organic diseases of which surgical treatment is prioritized by the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matsudo | Chiba | 270-2267 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32210639 | Derived | 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. |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| 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. | 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 |
| 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. | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days |
| 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. | 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 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 | Evaluation period which starts on 25th day after start of treatment and lasts for 140 days |
| Endometrial thickness | Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography. | 24 weeks after taking the initial study medication |
| 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. | Up to 24 weeks |
| Osaka |
| Osaka |
| 530-0013 |
| Japan |
| Osaka | Osaka | 542-0086 | Japan |
| HachiĆji | Tokyo | 192-0046 | Japan |
| Minato | Tokyo | 108-0071 | Japan |
| Setagaya-ku | Tokyo | 157-0066 | Japan |
| Suginami-ku | Tokyo | 167-0051 | Japan |
| Toshima-ku | Tokyo | 171-0021 | Japan |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |