check_circleStudy Completed
Metrorrhagia
Bayer Identifier:
91774
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study of a 4-phasic oral contraceptive for the treatment of heavy menstrual bleeding
Trial purpose
To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
339Trial Dates
June 2012 - June 2015Phase
Phase 3Could I Receive a placebo
NoProducts
Natazia/Qlaira (EV/DNG, BAY86-5027)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Singapore, 229899, Singapore | |
Terminated | Singapore, 169608, Singapore | |
Completed | Ivanovo, 153045, Russia | |
Completed | Krasnodar, 350012, Russia | |
Completed | Irkutsk, 664003, Russia | |
Completed | St. Petersburg, 199034, Russia | |
Terminated | Moscow, 119415, Russia | |
Completed | Bangkok, 10700, Thailand | |
Completed | Bangkok, 10330, Thailand | |
Completed | Manila, Philippines | |
Completed | Taipei, 100, Taiwan | |
Terminated | Taipei, 11217, Taiwan | |
Completed | Tainan, Taiwan | |
Completed | Quezon City, Philippines | |
Completed | Beijing, 100730, China | |
Completed | Shanghai, 200090, China | |
Completed | Beijing, 100730, China | |
Completed | Jinan, 250012, China | |
Completed | Guangzhou, 510120, China | |
Completed | Beijing, 100034, China | |
Completed | Beijing, 100044, China | |
Completed | Shenyang, 110004, China | |
Completed | Chongqing, 400010, China | |
Completed | Dalian, 116011, China | |
Completed | Shanghai, 200030, China | |
Completed | Wuhan, 430022, China | |
Completed | Xi'an, 710032, China | |
Terminated | Qingdao, 266071, China | |
Completed | Changchun, China | |
Completed | Tianjin, 300193, China | |
Completed | Tianjin, 300211, China | |
Completed | Shijiazhuang, 050051, China | |
Completed | Wuhan, 430030, China | |
Completed | Chengdu, 610072, China | |
Completed | Nanning, 530021, China | |
Completed | Beijing, 100026, China | |
Completed | Hengyang, 421001, China | |
Completed | Changsha, 410013, China | |
Completed | Taichung, 40705, Taiwan | |
Completed | Chengdu, 610041, China | |
Terminated | St. Petersburg, 194354, Russia | |
Completed | Moscow, 117049, Russia |
Primary Outcome
- Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 daysdate_rangeTime Frame:90 day baseline period and 90 days during treatment periodenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Proportion of subjects with successful treatmentSuccessful treatment is defined as no bleeding episode with MBL of 80 mL or more and a decrease to a value </=50% of MBL compared to 90 day run-in perioddate_rangeTime Frame:90 days during treatment phaseenhanced_encryptionNoSafety Issue:
- Percent change of MBL at baseline and 90 day period during treatment phasedate_rangeTime Frame:Baseline and 90 days during treatment phaseenhanced_encryptionNoSafety Issue:
- Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)date_rangeTime Frame:Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7enhanced_encryptionNoSafety Issue:
- Proportion of subjects with improvement in the investigator's global assessment scale on Day 84Investigator’s global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.date_rangeTime Frame:Treatment day 84enhanced_encryptionNoSafety Issue:
- Proportion of subjects with improvement in the investigator's global assessment scale on Day 196Investigator’s global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.date_rangeTime Frame:Treatment day 196enhanced_encryptionNoSafety Issue:
- Proportion of subjects with improvement in the subject's global assessment scale on Day 84Subject’s global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.date_rangeTime Frame:Treatment day 84enhanced_encryptionNoSafety Issue:
- Proportion of subjects with improvement in the subject's global assessment scale on Day 196Subject’s global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.date_rangeTime Frame:Treatment day 196enhanced_encryptionNoSafety Issue:
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 12 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2