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This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase.
The primary objective of this study is to confirm the superiority of BAY86-5300 when administered with an extended flexible regimen for the treatment of endometriosis-associated pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.
The secondary objective is to investigate the long-term safety of BAY86-5300 in patients treated with an extended flexible regimen for one year, and the bleeding pattern of BAY86-5300 when administered with an extended flexible regimen compared to dienogest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE20/DRSP(BAY86-5300) | Drug | One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24) | The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS) | Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24) |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain) | Pelvic pain is the worst pain on a 0-10 scale rated by the participant. | Weeks 17-24 of treatment period |
| Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anjo | Aichi-ken | 446-8510 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28911925 | Derived | Harada T, Kosaka S, Elliesen J, Yasuda M, Ito M, Momoeda M. Ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen for the management of endometriosis-associated pelvic pain: a randomized controlled trial. Fertil Steril. 2017 Nov;108(5):798-805. doi: 10.1016/j.fertnstert.2017.07.1165. Epub 2017 Sep 11. |
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| Placebo | Drug | One tablet (no active ingredient) / day and one tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day, for the first 24 weeks and the later 28 weeks, respectively |
|
| Dienogest | Drug | Dienogest 1mg twice a day (bid) |
|
Pelvic pain is the worst pain on a 0-10 scale rated by the participant. |
| Weeks 17-24 of treatment period |
| Dyspareunia | In case having sexual intercourse, dyspareunia pain is the worst pain on a 0-10 scale rated by the participant in the last 24 hours. | Weeks 17-24 of treatment period |
| Average of pain | The average of pain is the mean value of the Visual Analogue Scale (VAS) value during the time frame calculated for each patient based on daily record of Patient Diary. | Weeks 17-24 of treatment period |
| Size of chocolate cyst | In case chocolate cyst is detected, size of chocolate cyst is a mean length (mm) of the longest axis and the short axis (crossing) of the largest chocolate cyst determined by transvaginal ultrasonography. | 24 weeks after taking the initial study medication |
| 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 spotting/bleeding | Number of days with spotting/bleeding is determined based on daily record of Patient Diary. | Up to 52 weeks |
| Ichinomiya |
| Aichi-ken |
| 491-8551 |
| Japan |
| Nagoya | Aichi-ken | 451-8511 | Japan |
| Nagoya | Aichi-ken | 460-0011 | Japan |
| Nagoya | Aichi-ken | 464-0066 | Japan |
| Matsudo | Chiba | 270-2267 | Japan |
| Fukui-shi | Fukui | 910-0845 | Japan |
| Fukui-shi | Fukui | 910-8526 | Japan |
| Gifu | Gifu | 500-8717 | Japan |
| Takasaki | Gunma | 370-0883 | Japan |
| Itami | Hyōgo | 664-8540 | Japan |
| Kawanishi | Hyōgo | 666-0125 | Japan |
| Kobe | Hyōgo | 654-0047 | Japan |
| Kanazawa | Ishikawa-ken | 920-8530 | Japan |
| Kamakura | Kanagawa | 247-8533 | Japan |
| Kawasaki | Kanagawa | 212-0016 | Japan |
| Yokohama | Kanagawa | 230-0001 | Japan |
| Yokohama | Kanagawa | 231-0023 | Japan |
| Osaka | Osaka | 530-0001 | Japan |
| Osaka | Osaka | 530-0013 | Japan |
| Osaka | Osaka | 542-0086 | Japan |
| Toyonaka | Osaka | 560-0022 | Japan |
| Kitamoto | Saitama | 364-8501 | Japan |
| Bunkyo | Tokyo | 112-0014 | Japan |
| Chuo-ku | Tokyo | 104-0061 | Japan |
| Fuchū | Tokyo | 183-0056 | Japan |
| Hachiōji | Tokyo | 192-0046 | Japan |
| Machida | Tokyo | 194-0022 | Japan |
| Minato | Tokyo | 105-0001 | Japan |
| Minato | Tokyo | 107-0051 | Japan |
| Nishitōkyō | Tokyo | 188-0011 | Japan |
| tabashi City | Tokyo | 175-0092 | Japan |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C023635 | dienogest |
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