SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
NCT ID: NCT00511797
Last Updated: 2017-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
249 participants
INTERVENTIONAL
2007-07-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DRSP 1 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
SH T04740B
Drospirenone 1mg/EE 20µg (ß-CDC)
DRSP 2 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
SH T04740F
Drospirenone 2 mg/EE 20µg (ß-CDC)
DRSP 3 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
SH T00186DF
Drospirenone 3 mg/EE 20µg (ß-CDC)
Placebo
1 tablet per day placebo for 28 days in each 28-day cycle
Placebo
Placebo
Interventions
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SH T04740B
Drospirenone 1mg/EE 20µg (ß-CDC)
SH T00186DF
Drospirenone 3 mg/EE 20µg (ß-CDC)
SH T04740F
Drospirenone 2 mg/EE 20µg (ß-CDC)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment
* Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment
Exclusion Criteria
* Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear examination.)
* Patients with undiagnosed abnormal vaginal bleeding
* Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), or a history of those diseases
* Patients aged 35 years or older who smoke at least 15 cigarettes per day
* Patients with migraine accompanied by prodrome (e.g. scintillating scotoma or star-shaped scintillation)
* Patients with pulmonary hypertension or valvular heart disease complicated by atrial fibrillation, and patients with a history of subacute bacterial endocarditis
* Patients who are regularly taking nutritional products that contain St. John's Wort
* Patients who underwent surgical treatment for endometriosis by laparotomy, or laparoscopy within 2 months prior to screening
* Patients who need to use analgesics regularly for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
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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Maebashi, Gunma, Japan
Kobe, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Yokohama, Kanagawa, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Osaka, Osaka, Japan
Chuo-ku, Tokyo, Japan
Hachiōji, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Toshima-ku, Tokyo, Japan
Countries
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References
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Momoeda M, et al. Treatment of Functional and Organic Dysmenorrhea - Investigation of the Efficacy and Safety of Drospirenone/Ethinylestradiol Combination Tablet (YAZ). Sanka to Fujinka (Obstetrics and Gynecology), 2010: 77 (8) 977-88 (in Japanese)
Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.
Other Identifiers
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310283
Identifier Type: OTHER
Identifier Source: secondary_id
91615
Identifier Type: -
Identifier Source: org_study_id
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