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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00461305 |
The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety
Condition | Intervention | Phase |
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Dysmenorrhea |
Drug: Ethinylestradiol / Drospirenon ( SH TO4740B Drug: Ethinylestradiol / Drospirenon ( SH TO4740F) Drug: Ethinylestradiol / Drospirenon ( SH TOO186DF) Drug: Ethinylestradiol / Drospirenon |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Single-Blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 mg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles) |
Enrollment: | 416 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | July 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 3: Experimental |
Drug: Ethinylestradiol / Drospirenon ( SH TOO186DF)
DRSP 3 mg/EE 20 µg (ß-CDC)] (24 tablets)+ [placebo] (4 tablets)}are to be taken orally in the form of a single tablet once daily (the tablet is to be taken at a fixed time, but whether taken before or after a meal is unimportant) for 16 weeks (4 cycles).
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Arm 4: Placebo Comparator |
Drug: Ethinylestradiol / Drospirenon
[placebo] (24 tablets) + [placebo] (4 tablets) is to be taken orally in the form of a single tablet once daily (the tablet is to be taken at a fixed time, but whether taken before or after a meal is unimportant) for 16 weeks (4 cycles).
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Arm 1: Experimental |
Drug: Ethinylestradiol / Drospirenon ( SH TO4740B
DRSP 1 mg/EE 20 µg (ß-CDC)] (24 tablets)+ [placebo] (4 tablets) are to be taken orally in the form of a single tablet once daily (the tablet is to be taken at a fixed time, but whether taken before or after a meal is unimportant) for 16 weeks (4 cycles).
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Arm 2: Experimental |
Drug: Ethinylestradiol / Drospirenon ( SH TO4740F)
[DRSP 2 mg/EE 20 µg (ß-CDC)] (24 tablets)+ [placebo] (4 tablets)} are to be taken orally in the form of a single tablet once daily (the tablet is to be taken at a fixed time, but whether taken before or after a meal is unimportant) for 16 weeks (4 cycles)
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The SH T00186DF group is to be treated by oral administration for 52 weeks, 13 cycles. The SH T04740D group is to be treated by oral administration for 24 weeks, 6 cycles
The trial is sponsored by Bayer Schering Pharma AG, Germany.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Osaka, Japan, 530-0013 | |
Osaka, Japan, 534-0014 | |
Japan, Aichi | |
Nagoya, Aichi, Japan, 460-0011 | |
Nagoya, Aichi, Japan, 460-0007 | |
Nagoya, Aichi, Japan, 464-0066 | |
Japan, Gunma | |
Maebashi, Gunma, Japan, 371-0024 | |
Takasaki, Gunma, Japan, 370-0883 | |
Japan, Hyogo | |
Kobe, Hyogo, Japan, 650-0021 | |
Nishinomiya, Hyogo, Japan, 663-8204 | |
Japan, Kanagawa | |
Yokohama, Kanagawa, Japan, 231-0861 | |
Yamato, Kanagawa, Japan, 242-0007 | |
Japan, Miyagi | |
Sendai, Miyagi, Japan, 981-0933 | |
Sendai, Miyagi, Japan, 980-0021 | |
Sendai, Miyagi, Japan, 984-0042 | |
Japan, Osaka | |
Toyonaka, Osaka, Japan, 560-0022 | |
Japan, Tokyo | |
Suginami-ku, Tokyo, Japan, 167-0051 | |
Shinagawa-ku, Tokyo, Japan, 140-0013 | |
Ota-ku, Tokyo, Japan, 144-0052 | |
Setagaya-ku, Tokyo, Japan, 157-0066 | |
Setagaya-ku, Tokyo, Japan, 156-0042 | |
Machida, Tokyo, Japan, 194-0022 | |
Shibuya-ku, Tokyo, Japan, 150-0013 | |
Toshima-ku, Tokyo, Japan, 171-0021 | |
Musashino, Tokyo, Japan, 180-0003 | |
Hachioji, Tokyo, Japan, 192-0046 | |
Chuo-ku, Tokyo, Japan, 104-0061 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91616, 310284 |
Study First Received: | April 17, 2007 |
Last Updated: | July 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00461305 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Dysmenorrhea Intracyclic bleeding Drospirenone (DRSP) Ethinylestradiol |
Estrogens Hormone Antagonists Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Ethinyl Estradiol Pain Estradiol 17 beta-cypionate Hemorrhage Hormones |
Estradiol Signs and Symptoms Pelvic Pain Aldosterone Antagonists Dysmenorrhea Menstruation Disturbances Estradiol 3-benzoate Drospirenone Polyestradiol phosphate |
Estrogens Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Ethinyl Estradiol Pain Hormones Pharmacologic Actions |
Signs and Symptoms Pathologic Processes Pelvic Pain Aldosterone Antagonists Dysmenorrhea Menstruation Disturbances Drospirenone |