check_circleStudy Completed
Dysmenorrhea
Bayer Identifier:
91616
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Safety study of Ethinylestradiol/Drospirenone in dysmenorrhea
Trial purpose
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
Key Participants Requirements
Sex
FemaleAge
20 YearsTrial summary
Enrollment Goal
420Trial Dates
February 2007 - August 2009Phase
Phase 2/Phase 3Could I Receive a placebo
NoProducts
YAZ (EE20/DRSP, BAY86-5300)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Koga Clinic | Sendai, 981-0933, Japan |
Completed | Kakuta Chieko Clinic | Sendai, 984-0042, Japan |
Completed | Yazaki Clinic | Takasaki, 370-0883, Japan |
Completed | Takane Clinic | Shinagawa-ku, 140-0013, Japan |
Completed | Seijo Kinoshita Hospital | Setagaya-ku, 157-0066, Japan |
Completed | Kosugi Clinic | Setagaya-ku, 156-0042, Japan |
Completed | Women's Wellness Ginza Clinic | Chuo-ku, 104-0061, Japan |
Completed | C:z Ladies Clinic | Shibuya-ku, 150-0013, Japan |
Completed | NS Clinic | Hachioji, 192-0046, Japan |
Completed | Machida Higashiguchi Clinic | Machida, 194-0022, Japan |
Completed | Iida Ladies Clinic | Nagoya, 460-0007, Japan |
Completed | Sakie Ladies Clinic | Nagoya, 464-0066, Japan |
Completed | Chayamachi Ladies Clinic | Osaka, 530-0013, Japan |
Completed | Kawabata Women's Clinic | Osaka, 534-0014, Japan |
Completed | Nagaike Clinic | Sendai, 980-0021, Japan |
Completed | Iesaka Clinic | Maebashi, 371-0024, Japan |
Completed | Suzuran Clinic | Suginami-ku, 167-0051, Japan |
Completed | Ito Medical Clinic | Ota-ku, 144-0052, Japan |
Completed | Ikebukuro Clinic | Toshima-ku, 171-0021, Japan |
Completed | Kichijyouji Lady's Clinic | Musashino, 180-0003, Japan |
Completed | Luna Clinic | Yokohama, 231-0861, Japan |
Completed | Rinkan Clinic | Yamato, 242-0007, Japan |
Completed | Kano's Clinic for Women | Nagoya, 460-0011, Japan |
Completed | Yoshimura Ladies Clinic | Toyonaka, 560-0022, Japan |
Completed | Hanabusa Clinic | Kobe, 650-0021, Japan |
Completed | Kiuchi Ladies Clinic | Nishinomiya, 663-8204, Japan |
Primary Outcome
- Number of participants with intracyclic bleeding at Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with a change in Total Dysmenorrhea Score from baseline to Cycle 6date_rangeTime Frame:From baseline up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of participants with a change in Total Dysmenorrhea Score from baseline to Cycle 13date_rangeTime Frame:From baseline up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Total Dysmenorrhea Score at Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Total Dysmenorrhea Score at Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Severity of lower abdominal pain during menstruation at Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Severity of lower abdominal pain during menstruation at Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Severity of lumbago during menstruation at Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Severity of lumbago during menstruation at Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Severity of headache during menstruation at Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Severity of headache during menstruation at Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Severity of nausea or vomiting during menstruation at Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Distribution of Severity of nausea or vomiting during menstruation at Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of participants with a Total Pelvic Pain Score of 0 up to 6 at times other than during menstruation at Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of participants with a Total Pelvic Pain Score of 0 up to 6 at times other than during menstruation at Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Change in Visual Analogue Scale (VAS) for dysmenorrhea at times other than during menstruation from baseline to Cycle 6date_rangeTime Frame:From baseline up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Change in Visual Analogue Scale (VAS) for dysmenorrhea at times other than during menstruation from baseline to Cycle 13date_rangeTime Frame:From baseline up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Change in Visual Analogue Scale (VAS) for pelvic pain at times other than during menstruation from baseline to Cycle 6date_rangeTime Frame:From baseline up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Change in Visual Analogue Scale (VAS) for pelvic pain at times other than during menstruation from baseline to Cycle 13date_rangeTime Frame:From baseline up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of Any Bleeding Episodes from Cycle 1 to Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of Any Bleeding Episodes from Cycle 1 to Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of Any Bleeding Days from Cycle 1 to Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of any bleeding days from Cycle 1 to Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of participants with intracyclic bleeding from Cycle 1 to Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of participants with intracyclic bleeding from Cycle 1 to Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of participants with withdrawal bleeding from Cycle 1 to Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Number of participants with withdrawal bleeding from Cycle 1 to Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6date_rangeTime Frame:Up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13date_rangeTime Frame:Up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Change in serum carbohydrate antigen-125 (CA-125) from baseline to Cycle 6date_rangeTime Frame:From baseline up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Change in serum CA-125 from baseline to Cycle 13date_rangeTime Frame:From baseline up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Change in serum C-reactive protein (CRP) from baseline to Cycle 6date_rangeTime Frame:From baseline up to Cycle 6 (168 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
- Change in serum CRP from baseline to Cycle 13date_rangeTime Frame:From baseline up to Cycle 13 (364 days) with 28 days per cycleenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
2