Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis
NCT ID: NCT01697111
Last Updated: 2016-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
312 participants
INTERVENTIONAL
2012-10-31
2014-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
EE20/DRSP(BAY86-5300)
One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day
Arm 2
Placebo
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
Arm 3
Dienogest
Dienogest 1mg twice a day (bid)
Interventions
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EE20/DRSP(BAY86-5300)
One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day
Placebo
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
Dienogest 1mg twice a day (bid)
Eligibility Criteria
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Inclusion Criteria
* Patient with pelvic pain judged by the highest Visual Analogue Scale (VAS) value of 40 mm or higher which is determined during 2 menstrual cycles before randomization (baseline observation phase)
* Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
* Patients who do not wish to become pregnant during the course of the study
Exclusion Criteria
* Patients in whom any hormonal therapies, including combined oral contraceptives (COCs) and progestins, have failed for treatment of symptomatic endometriosis (moderate, severe pain)
* Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
* Patients for whom dienogest is contraindicated (according to Japanese labeling of Dinagest Tab 1mg)
20 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Anjo, Aichi-ken, Japan
Ichinomiya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Matsudo, Chiba, Japan
Fukui-shi, Fukui, Japan
Fukui-shi, Fukui, Japan
Gifu, Gifu, Japan
Takasaki, Gunma, Japan
Itami, Hyōgo, Japan
Kawanishi, Hyōgo, Japan
Kobe, Hyōgo, Japan
Kanazawa, Ishikawa-ken, Japan
Kamakura, Kanagawa, Japan
Kawasaki, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Toyonaka, Osaka, Japan
Kitamoto, Saitama, Japan
Bunkyo, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Fuchū, Tokyo, Japan
Hachiōji, Tokyo, Japan
Machida, Tokyo, Japan
Minato, Tokyo, Japan
Minato, Tokyo, Japan
Nishitōkyō, Tokyo, Japan
tabashi City, Tokyo, Japan
Countries
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References
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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.
Other Identifiers
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15457
Identifier Type: -
Identifier Source: org_study_id
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