Trial Condition(s):
Primary Dysmenorrhea
Effect on primary dysmenorrhea
Bayer Identifier:
91781
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
Inclusion Criteria
- Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score - Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent - Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit) - Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1. - Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.
Exclusion Criteria
- Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment) - Obesity: body mass index (BMI) > 32 kg/m2 - Hypersensitivity to any of the study drug ingredients - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results - Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding - Abuse of alcohol, drugs, or medicines (e.g. laxatives) - Other contraceptive methods: -- Sterilization -- Oral, vaginal or transdermal hormonal contraception during treatment -- Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1 - Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator - Major surgery scheduled for the study period
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Universitätsklinikum Freiburg Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Evangelisches Krankenhaus Köln Weyertal gGmbH Köln, Germany, 50931 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Vernon Clinical Research, LLC Sandy Springs, United States, 30328 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rosemark Women Care Specialist Idaho Falls, United States, 83404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trials Research Services, LLC Pittsburgh, United States, 15206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AGA Clinical Trials Hialeah, United States, 33012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Wisconsin - La Crosse La Crosse, United States, 54691 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lyndhurst Clinical Research Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Azienda Policlinico Umberto I Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Modena Policlinico Modena, Italy, 41124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Brindisi - Puglia Francavilla Fontana, Italy, 72021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Michael's Hospital Health Centre Toronto, Canada, M5C 2T2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H. Gerlach Essen, Germany, 45127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Peters Hamburg, Germany, 22159 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H.-J. Ahrendt Magdeburg, Germany, 39126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. A. Heweker Bernburg, Germany, 06406 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Alfred Moffett, MD Leesburg, United States, 34748 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genova Clinical Research, Inc. Tucson, United States, 85741 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Senese Siena, Italy, 53100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Santa Maria Misericordia UD Udine, Italy, 33100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. OIRM - S.Anna Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Spedali Civili Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Fatebenefratelli e Oftalmico Milano, Italy, 20121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Perugia Perugia, Italy, 06156 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Glover Medical Clinic Langley, Canada, V3A 4H9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regina Medical Centre Regina, Canada, S4P 3X1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorio del Dr. Castiglione Santiago, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Las Condes Santiago de Chile, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Chileno de Medicina Reproductiva Santiago de Chile, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universidad de Chile Santiago, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Philippine General Hospital Metro Manila, Philippines, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospice and Palliative Cener Cebu City, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Médicale des Campus Ste-Foy, Canada, G1V 4X7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kells Medical Research Group, Inc. Pointe-Claire, Canada, H9R 4S3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universidad de Concepcion Hospital Las Higueras Talcahuano, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorio Miraflores Temuco, Chile, 4790711 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Manila Doctors Hospital Metro Manila, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chong Hua Hospital Cebu, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Luke’s Medical Center Quezon City, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Tower Davao, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multi-center, double-blind, double-dummy, randomized, controlled, parallel-group study to assess efficacy and safety of SH T00658ID compared to SH D593B in the treatment of primary dysmenorrhea
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change between baseline evaluation period and treatment evaluation period in the number of days with dysmenorrheric painTimeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Secondary Outcome
- Change between baseline evaluation period and treatment evaluation period in the sum of score points of dysmenorrheric painTimeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
- Change between baseline evaluation period and treatment evaluation period in number of days with pelvic pain independent of occurrence of vaginal bleedingTimeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
- Change between baseline evaluation period and treatment evaluation period in number of days with pelvic pain during unscheduled bleedingTimeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
- Change between baseline evaluation period and treatment evaluation period in rescue medication use (only bleeding episode used including the two days before the episode)Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
- Change between baseline evaluation period and treatment evaluation period in rescue medication use (entire evaluation period used)Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
- 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)Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
- Percentage of participants with interference of dysmenorrheic pain with work/school and social or other activity (entire evaluation period used)Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
- Percentage of participants satisfied with study treatmentTimeframe: From cycle 1 to cycle 3 (28 days per cycle)
- Number of days with bleeding or spottingTimeframe: From day 1 to day 90
- Number of episodes with bleeding or spottingTimeframe: From day 1 to day 90
- Mean length of bleeding or spotting episodesTimeframe: From day 1 to day 90
- Maximum length of bleeding or spotting episodesTimeframe: From day 1 to day 90
- Difference in duration between longest and shortest bleeding or spotting episodesTimeframe: From day 1 to day 90
- Number of days with spotting-onlyTimeframe: From day 1 to day 90
- Number of episodes with spotting-onlyTimeframe: From day 1 to day 90
- Mean length of spotting only episodesTimeframe: From day 1 to day 90
- Maximum length of spotting only episodesTimeframe: From day 1 to day 90
- Difference in duration between longest and shortest spotting only episodeTimeframe: From day 1 to day 90
- Percentage of participants with withdrawal bleeding at cycle 1Timeframe: At cycle 1 (28 days per cycle)
- Percentage of participants with withdrawal bleeding at cycle 3Timeframe: At cycle 3 (28 days per cycle)
- Length of withdrawal bleeding episodes at cycle 1Timeframe: At cycle 1 (28 days per cycle)
- Length of withdrawal bleeding episodes at cycle 3Timeframe: At cycle 3 (28 days per cycle)
- Maximum intensity of withdrawal bleeding episodes at cycle 1Timeframe: At cycle 1 (28 days per cycle)
- Maximum intensity of withdrawal bleeding episodes at cycle 3Timeframe: At cycle 3 (28 days per cycle)
- Onset of withdrawal bleeding episodes at cycle 1Timeframe: At cycle 1 (28 days per cycle)
- Onset of withdrawal bleeding episodes at cycle 3Timeframe: At cycle 3 (28 days per cycle)
- Percentage of participants with intracyclic bleeding at cycle 1Timeframe: At cycle 1 (28 days per cycle)
- Percentage of participants with intracyclic bleeding at cycle 3Timeframe: At cycle 3 (28 days per cycle)
- Number of intracyclic bleeding episodes at cycle 1Timeframe: At cycle 1 (28 days per cycle)
- Number of intracyclic bleeding episodes at cycle 3Timeframe: At cycle 3 (28 days per cycle)
- Maximum length of intracyclic bleeding episodes at cycle 1Timeframe: At cycle 1 (28 days per cycle)
- Maximum length of intracyclic bleeding episodes at cycle 3Timeframe: At cycle 3 (28 days per cycle)
- Number of intracyclic bleeding days at cycle 1Timeframe: At cycle 1 (28 days per cycle)
- Number of intracyclic bleeding days at cycle 3Timeframe: At cycle 3 (28 days per cycle)
- Percentage of participants with maximum intensity of intracyclic bleeding episodes at cycle 1Timeframe: At cycle 1 (28 days per cycle)
- Percentage of participants with maximum intensity of intracyclic bleeding episodes at cycle 3Timeframe: At cycle 3 (28 days per cycle)
- Percentage of participants missing time from work due to dysmenorrheic pain at screeningTimeframe: At screening (28 days)
- Percentage of participants missing time from work due to dysmenorrheic pain at baseline cycleTimeframe: At Baseline (28 days per cycle)
- Percentage of participants missing time from work due to dysmenorrheic pain at cycle 2Timeframe: At cycle 2 (28 days per cycle)
- Percentage of participants missing time from work to dysmenorrheic pain at final examinationTimeframe: At final examination (28 days)
- Own costs of physiotherapy per treatment converted to U.S. dollars as measured by Resource Use QuestionaireTimeframe: At screening (average over 3 months before screening)
- Own costs of pain medication per treatment converted to U.S. dollars as measured by Resource Use QuestionaireTimeframe: At screening (average over 3 months before screening)
- Own costs of vitamins per treatment converted to U.S. dollars as measured by resources Use QuestionaireTimeframe: At screening (average over 3 months before screening)
- Own costs of massages per treatment converted to U.S. dollars as measured by Resource Use QuestionaireTimeframe: At screening (average over 3 months before screening)
- Own costs of accupuncture per treatment converted to U.S. dollars as measured by Resource of Use QuestionaireTimeframe: At screening (average over 3 months before screening)
- Own costs of medical counseling per treatment converted to U.S. dollars as measured by Resource Use QuestionaireTimeframe: At screening (average over 3 months before screening)
- Own costs of alternative medicine per treatment converted to U.S. dollars as measured by Recource Use QuestionaireTimeframe: At screening (average over 3 months before screening)
- Own costs of herbs/teas per treatment converted to U.S. dollars as measured by Resource Use QuestionaireTimeframe: At screening (average over 3 months before screening)
- Other own costs per treatment converted to U.S. dollars measured by Resource Use QuestionaireTimeframe: At screening (average over 3 months before screening)
- Participants with improvement in the investigator's assessment in the Clinical Global ImpressionTimeframe: At cycle 2 (28 days per cycle)
- Participants with improvement in participants' assessment in the Clinical Global ImpressionTimeframe: At cycle 2 (28 days per cycle)
- Physical functioning as measured by General health and well.being questionaire SF-36 at baseline cycleTimeframe: At baseline cycle (28 days per cycle)
- Physical functioning as measured by general health and well-being questionaire SF-36 at final examinationTimeframe: at final examiniation (28 days)
- Social functioning as measured by General health and well-being questionaire SF-36 at baseline cycleTimeframe: At baseline cycle (28 days per cycle)
- Social functioning as measured by General health and well-being questionaire SF-36 at final examinationTimeframe: At final examination (28 days)
- Mental health as measured by General health and well-being questionaire SF-36 at baseline cycleTimeframe: At baseline cycle (28 days per cycle)
- Mental health as measured by General health and well-being questionaire SF-36 at final examinationTimeframe: At final examination (28 days)
- Vitality as measured by General health and well-being questionaire SF-36 at baseline cycleTimeframe: At baseline cycle (28 days per cycle)
- Vitality as measured by General health and well-being questionaire SF-36 at final examinationTimeframe: At final examination (28 days)
- General health as measured by General health and well-being questionaire SF-36 at baseline cycleTimeframe: At baseline cycle (28 days per cycle)
- General health as measured by general health and well-being questionaire SF-36 at final examinationTimeframe: At final examination (28 days)
- Role physical as measured by General health and well-being questionaire SF-36 at baseline cycleTimeframe: At baseline cycle (28 days per cycle)
- Role physical as measured by General health and well-being questionaire SF-36 at final examinationTimeframe: At final examination (28 days)
- Role emotional as measured by general health and well-being questionaire SF-36 at baseline cycleTimeframe: At baseline cycle (28 days per cycle)
- Role emotional as mesured by General health and well-being questionaire SF-36 at final examinationTimeframe: At final examination (28 days)
- Bodily pain as measured by General health well-being questionaire SF-36 at baseline cycleTimeframe: At baseline cycle (28 days per cycle)
- Bodily pain as measured by General health and well-being questionaire SF-36 at final examinationTimeframe: At final examination (28 days)
Additional Information
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