check_circleStudy Completed
Primary Dysmenorrhea
Bayer Identifier:
91781
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Effect on primary dysmenorrhea
Trial purpose
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
Key Participants Requirements
Sex
FemaleAge
14 - 50 YearsTrial summary
Enrollment Goal
507Trial Dates
April 2009 - November 2010Phase
Phase 3Could I Receive a placebo
YesProducts
Natazia/Qlaira (EV/DNG, BAY86-5027)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätsklinikum Freiburg | Freiburg, 79106, Germany |
Completed | Frauenarztpraxis Dr. Bernd Pittner | Leipzig, 04207, Germany |
Completed | Evangelisches Krankenhaus Köln Weyertal gGmbH | Köln, 50931, Germany |
Completed | Mount Vernon Clinical Research, LLC | Sandy Springs, 30328, United States |
Completed | Rosemark Women Care Specialist | Idaho Falls, 83404, United States |
Completed | Clinical Trials Research Services, LLC | Pittsburgh, 15206, United States |
Completed | AGA Clinical Trials | Hialeah, 33012, United States |
Completed | University of Wisconsin - La Crosse | La Crosse, 54691, United States |
Completed | Lyndhurst Clinical Research | Winston-Salem, 27103, United States |
Completed | Azienda Policlinico Umberto I | Roma, 00161, Italy |
Completed | A.O.U. di Modena Policlinico | Modena, 41124, Italy |
Completed | A.O.U. di Bologna | Bologna, 40138, Italy |
Completed | AUSL Brindisi - Puglia | Francavilla Fontana, 72021, Italy |
Completed | St. Michael's Hospital Health Centre | Toronto, M5C 2T2, Canada |
Completed | Praxis Hr. Dr. H. Gerlach | Essen, 45127, Germany |
Completed | Praxis Hr. Dr. K. Peters | Hamburg, 22159, Germany |
Completed | Praxis Hr. Prof. Dr. H.-J. Ahrendt | Magdeburg, 39126, Germany |
Completed | Praxis Fr. A. Heweker | Bernburg, 06406, Germany |
Completed | Clinical Research of Philadelphia, LLC | Philadelphia, 19114, United States |
Completed | Office of Dr. Alfred Moffett, MD | Leesburg, 34748, United States |
Completed | Medical Center for Clinical Research | San Diego, 92108, United States |
Completed | Genova Clinical Research, Inc. | Tucson, 85741, United States |
Completed | A.O.U. Senese | Siena, 53100, Italy |
Completed | A.O.U. Santa Maria Misericordia UD | Udine, 33100, Italy |
Completed | A.O. OIRM - S.Anna | Torino, 10126, Italy |
Completed | A.O. Spedali Civili | Brescia, 25123, Italy |
Completed | A.O. Fatebenefratelli e Oftalmico | Milano, 20121, Italy |
Completed | A.O.U. di Perugia | Perugia, 06156, Italy |
Completed | Glover Medical Clinic | Langley, V3A 4H9, Canada |
Terminated | Regina Medical Centre | Regina, S4P 3X1, Canada |
Completed | Consultorio del Dr. Castiglione | Santiago, Chile |
Completed | Clínica Las Condes | Santiago de Chile, Chile |
Completed | Instituto Chileno de Medicina Reproductiva | Santiago de Chile, Chile |
Terminated | Hospital Clínico Universidad de Chile | Santiago, Chile |
Completed | Philippine General Hospital | Metro Manila, 1000, Philippines |
Terminated | Hospice and Palliative Cener | Cebu City, Philippines |
Completed | Clinique Médicale des Campus | Ste-Foy, G1V 4X7, Canada |
Completed | Kells Medical Research Group, Inc. | Pointe-Claire, H9R 4S3, Canada |
Completed | Universidad de Concepcion Hospital Las Higueras | Talcahuano, Chile |
Completed | Consultorio Miraflores | Temuco, 4790711, Chile |
Terminated | Manila Doctors Hospital | Metro Manila, Philippines |
Completed | Chong Hua Hospital | Cebu, Philippines |
Completed | St. Luke’s Medical Center | Quezon City, Philippines |
Completed | Medical Tower | Davao, Philippines |
Primary Outcome
- Change between baseline evaluation period and treatment evaluation period in the number of days with dysmenorrheric paindate_rangeTime Frame:baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change between baseline evaluation period and treatment evaluation period in the sum of score points of dysmenorrheric paindate_rangeTime Frame:baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)enhanced_encryptionNoSafety Issue:
- Change between baseline evaluation period and treatment evaluation period in number of days with pelvic pain independent of occurrence of vaginal bleedingdate_rangeTime Frame:baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)enhanced_encryptionNoSafety Issue:
- Change between baseline evaluation period and treatment evaluation period in number of days with pelvic pain during unscheduled bleedingdate_rangeTime Frame:baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)enhanced_encryptionNoSafety Issue:
- Change between baseline evaluation period and treatment evaluation period in rescue medication use (only bleeding episode used including the two days before the episode)date_rangeTime Frame:baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)enhanced_encryptionNoSafety Issue:
- Change between baseline evaluation period and treatment evaluation period in rescue medication use (entire evaluation period used)date_rangeTime Frame:baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)enhanced_encryptionNoSafety Issue:
- Percentage of participants with interference of dysmenorrheic pain with work/school and social or other activity (only bleeding episode used including the two days before)date_rangeTime Frame:baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)enhanced_encryptionNoSafety Issue:
- Percentage of participants with interference of dysmenorrheic pain with work/school and social or other activity (entire evaluation period used)date_rangeTime Frame:baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)enhanced_encryptionNoSafety Issue:
- Percentage of participants satisfied with study treatmentdate_rangeTime Frame:From cycle 1 to cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of days with bleeding or spottingdate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Number of episodes with bleeding or spottingdate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Mean length of bleeding or spotting episodesdate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Maximum length of bleeding or spotting episodesdate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Difference in duration between longest and shortest bleeding or spotting episodesdate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Number of days with spotting-onlydate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Number of episodes with spotting-onlydate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Mean length of spotting only episodesdate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Maximum length of spotting only episodesdate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Difference in duration between longest and shortest spotting only episodedate_rangeTime Frame:From day 1 to day 90enhanced_encryptionNoSafety Issue:
- Percentage of participants with withdrawal bleeding at cycle 1date_rangeTime Frame:At cycle 1 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Percentage of participants with withdrawal bleeding at cycle 3date_rangeTime Frame:At cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Length of withdrawal bleeding episodes at cycle 1date_rangeTime Frame:At cycle 1 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Length of withdrawal bleeding episodes at cycle 3date_rangeTime Frame:At cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Maximum intensity of withdrawal bleeding episodes at cycle 1date_rangeTime Frame:At cycle 1 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Maximum intensity of withdrawal bleeding episodes at cycle 3date_rangeTime Frame:At cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Onset of withdrawal bleeding episodes at cycle 1date_rangeTime Frame:At cycle 1 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Onset of withdrawal bleeding episodes at cycle 3date_rangeTime Frame:At cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Percentage of participants with intracyclic bleeding at cycle 1date_rangeTime Frame:At cycle 1 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Percentage of participants with intracyclic bleeding at cycle 3date_rangeTime Frame:At cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of intracyclic bleeding episodes at cycle 1date_rangeTime Frame:At cycle 1 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of intracyclic bleeding episodes at cycle 3date_rangeTime Frame:At cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Maximum length of intracyclic bleeding episodes at cycle 1date_rangeTime Frame:At cycle 1 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Maximum length of intracyclic bleeding episodes at cycle 3date_rangeTime Frame:At cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of intracyclic bleeding days at cycle 1date_rangeTime Frame:At cycle 1 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Number of intracyclic bleeding days at cycle 3date_rangeTime Frame:At cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Percentage of participants with maximum intensity of intracyclic bleeding episodes at cycle 1date_rangeTime Frame:At cycle 1 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Percentage of participants with maximum intensity of intracyclic bleeding episodes at cycle 3date_rangeTime Frame:At cycle 3 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Percentage of participants missing time from work due to dysmenorrheic pain at screeningdate_rangeTime Frame:At screening (28 days)enhanced_encryptionNoSafety Issue:
- Percentage of participants missing time from work due to dysmenorrheic pain at baseline cycledate_rangeTime Frame:At Baseline (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Percentage of participants missing time from work due to dysmenorrheic pain at cycle 2date_rangeTime Frame:At cycle 2 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Percentage of participants missing time from work to dysmenorrheic pain at final examinationdate_rangeTime Frame:At final examination (28 days)enhanced_encryptionNoSafety Issue:
- Own costs of physiotherapy per treatment converted to U.S. dollars as measured by Resource Use Questionairedate_rangeTime Frame:At screening (average over 3 months before screening)enhanced_encryptionNoSafety Issue:
- Own costs of pain medication per treatment converted to U.S. dollars as measured by Resource Use Questionairedate_rangeTime Frame:At screening (average over 3 months before screening)enhanced_encryptionNoSafety Issue:
- Own costs of vitamins per treatment converted to U.S. dollars as measured by resources Use Questionairedate_rangeTime Frame:At screening (average over 3 months before screening)enhanced_encryptionNoSafety Issue:
- Own costs of massages per treatment converted to U.S. dollars as measured by Resource Use Questionairedate_rangeTime Frame:At screening (average over 3 months before screening)enhanced_encryptionNoSafety Issue:
- Own costs of accupuncture per treatment converted to U.S. dollars as measured by Resource of Use Questionairedate_rangeTime Frame:At screening (average over 3 months before screening)enhanced_encryptionNoSafety Issue:
- Own costs of medical counseling per treatment converted to U.S. dollars as measured by Resource Use Questionairedate_rangeTime Frame:At screening (average over 3 months before screening)enhanced_encryptionNoSafety Issue:
- Own costs of alternative medicine per treatment converted to U.S. dollars as measured by Recource Use Questionairedate_rangeTime Frame:At screening (average over 3 months before screening)enhanced_encryptionNoSafety Issue:
- Own costs of herbs/teas per treatment converted to U.S. dollars as measured by Resource Use Questionairedate_rangeTime Frame:At screening (average over 3 months before screening)enhanced_encryptionNoSafety Issue:
- Other own costs per treatment converted to U.S. dollars measured by Resource Use Questionairedate_rangeTime Frame:At screening (average over 3 months before screening)enhanced_encryptionNoSafety Issue:
- Participants with improvement in the investigator's assessment in the Clinical Global Impressiondate_rangeTime Frame:At cycle 2 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Participants with improvement in participants' assessment in the Clinical Global Impressiondate_rangeTime Frame:At cycle 2 (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Physical functioning as measured by General health and well.being questionaire SF-36 at baseline cycledate_rangeTime Frame:At baseline cycle (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Physical functioning as measured by general health and well-being questionaire SF-36 at final examinationdate_rangeTime Frame:at final examiniation (28 days)enhanced_encryptionNoSafety Issue:
- Social functioning as measured by General health and well-being questionaire SF-36 at baseline cycledate_rangeTime Frame:At baseline cycle (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Social functioning as measured by General health and well-being questionaire SF-36 at final examinationdate_rangeTime Frame:At final examination (28 days)enhanced_encryptionNoSafety Issue:
- Mental health as measured by General health and well-being questionaire SF-36 at baseline cycledate_rangeTime Frame:At baseline cycle (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Mental health as measured by General health and well-being questionaire SF-36 at final examinationdate_rangeTime Frame:At final examination (28 days)enhanced_encryptionNoSafety Issue:
- Vitality as measured by General health and well-being questionaire SF-36 at baseline cycledate_rangeTime Frame:At baseline cycle (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Vitality as measured by General health and well-being questionaire SF-36 at final examinationdate_rangeTime Frame:At final examination (28 days)enhanced_encryptionNoSafety Issue:
- General health as measured by General health and well-being questionaire SF-36 at baseline cycledate_rangeTime Frame:At baseline cycle (28 days per cycle)enhanced_encryptionNoSafety Issue:
- General health as measured by general health and well-being questionaire SF-36 at final examinationdate_rangeTime Frame:At final examination (28 days)enhanced_encryptionNoSafety Issue:
- Role physical as measured by General health and well-being questionaire SF-36 at baseline cycledate_rangeTime Frame:At baseline cycle (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Role physical as measured by General health and well-being questionaire SF-36 at final examinationdate_rangeTime Frame:At final examination (28 days)enhanced_encryptionNoSafety Issue:
- Role emotional as measured by general health and well-being questionaire SF-36 at baseline cycledate_rangeTime Frame:At baseline cycle (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Role emotional as mesured by General health and well-being questionaire SF-36 at final examinationdate_rangeTime Frame:At final examination (28 days)enhanced_encryptionNoSafety Issue:
- Bodily pain as measured by General health well-being questionaire SF-36 at baseline cycledate_rangeTime Frame:At baseline cycle (28 days per cycle)enhanced_encryptionNoSafety Issue:
- Bodily pain as measured by General health and well-being questionaire SF-36 at final examinationdate_rangeTime Frame:At final examination (28 days)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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