check_circleStudy Completed
Dysmenorrhea
Bayer Identifier:
91615
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
SH T00186 Phase II/ III optimal Drospirenone (DRSP) dose finding and placebo-controlled comparative study
Trial purpose
The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.
Key Participants Requirements
Sex
FemaleAge
20 - N/ATrial summary
Enrollment Goal
249Trial Dates
July 2007 - January 2009Phase
Phase 2/Phase 3Could I Receive a placebo
YesProducts
YAZ (EE20/DRSP, BAY86-5300)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Maebashi, 371-0024, Japan | |
Completed | Setagaya-ku, 157-0066, Japan | |
Completed | Toshima-ku, 171-0021, Japan | |
Completed | Yokohama, 231-0861, Japan | |
Completed | Osaka, 530-0013, Japan | |
Completed | Nishinomiya, 663-8204, Japan | |
Completed | Sendai, 981-0933, Japan | |
Completed | Setagaya-ku, 156-0042, Japan | |
Completed | Chuo-ku, 104-0061, Japan | |
Completed | Kobe, 650-0021, Japan | |
Completed | Hachioji, 192-0046, Japan | |
Completed | Kyoto, 612-0064, Japan |
Primary Outcome
- Change from baseline in total dysmenorrheal score at final evaluationdate_rangeTime Frame:Baseline and up to 4 Cycles (28 days per cycle)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change from baseline in total dysmenorrheal score at Cycle 1 up to Cycle 4date_rangeTime Frame:Baseline and up to 4 Cycles (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of participants with severity of lower abdominal pain during menstruation at Cycle 4date_rangeTime Frame:Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of participants with severity of low back pain during menstruation at Cycle 4date_rangeTime Frame:Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of participants with severity of headache during menstruation at Cycle 4date_rangeTime Frame:Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of participants with severity of nausea or vomiting during menstruation at Cycle 4date_rangeTime Frame:Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of participants with total pelvic pain score at times other than during menstruation at Cycle 4date_rangeTime Frame:Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Change from baseline in Visual Analogue Scale (VAS) for dysmenorrhea at times other than during menstruation at Cycle 4date_rangeTime Frame:From baseline up to Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Visual Analogue Scale (VAS) for pelvic pain at times other than during menstruation at Cycle 4date_rangeTime Frame:Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Change from baseline in endometrial thickness after 4-cycle treatmentdate_rangeTime Frame:From baseline to Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of bleeding / spotting episodesdate_rangeTime Frame:For the first 90 daysenhanced_encryptionNoSafety Issue:
- Number of bleeding / spotting daysdate_rangeTime Frame:For the first 90 daysenhanced_encryptionNoSafety Issue:
- Participants with withdrawal bleedingdate_rangeTime Frame:At Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Participants with intracyclic bleedingdate_rangeTime Frame:At Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Participants with non-heavy intracyclic bleedingdate_rangeTime Frame:At Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Participants with non-heavy withdrawal bleedingdate_rangeTime Frame:At Cycle 4 (28 dyas per cycle)enhanced_encryptionNoSafety Issue:
- Change from baseline in serum carbohydrate antigen-125 (CA125) after 4-cycle treatmentdate_rangeTime Frame:From baseline to Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Change from baseline in serum C-reactive protein (CRP) after 4-cycle treatmentdate_rangeTime Frame:From baseline to Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Change from baseline in serum estradiol level after 4-cycle treatmentdate_rangeTime Frame:From baseline to Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Change from baseline in serum progesterone level at Cycle 4date_rangeTime Frame:From baseline to Cycle 4 (28 days per cycle)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4