Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
507 participants
INTERVENTIONAL
2009-04-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
Placebo Match to SH T00658ID
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Ethinyl estradiol, Levonorgestrel (Miranova)
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Ethinyl estradiol, Levonorgestrel (Miranova)
Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval
Placebo Match to SH D593B
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Interventions
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Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
Ethinyl estradiol, Levonorgestrel (Miranova)
Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval
Placebo Match to SH T00658ID
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Placebo Match to SH D593B
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
50 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Tucson, Arizona, United States
San Diego, California, United States
Hialeah, Florida, United States
Leesburg, Florida, United States
Sandy Springs, Georgia, United States
Idaho Falls, Idaho, United States
Winston-Salem, North Carolina, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
La Crosse, Wisconsin, United States
Langley, British Columbia, Canada
Toronto, Ontario, Canada
Pointe-Claire, Quebec, Canada
Ste-Foy, Quebec, Canada
Regina, Saskatchewan, Canada
Santiago, , Chile
Talcahuano, , Chile
Temuco, , Chile
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Hamburg, City state of Hamburg, Germany
Cologne, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Leipzig, Saxony, Germany
Bernburg, Saxony-Anhalt, Germany
Magdeburg, Saxony-Anhalt, Germany
Francavilla Fontana, Brindisi, Italy
Bologna, , Italy
Brescia, , Italy
Milan, , Italy
Modena, , Italy
Perugia, , Italy
Roma, , Italy
Siena, , Italy
Torino, , Italy
Udine, , Italy
Cebu, , Philippines
Cebu City, , Philippines
Davao City, , Philippines
Metro Manila, , Philippines
Metro Manila, , Philippines
Quezon City, , Philippines
Countries
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References
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Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.
Petraglia F, Parke S, Serrani M, Mellinger U, Romer T. Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea. Int J Gynaecol Obstet. 2014 Jun;125(3):270-4. doi: 10.1016/j.ijgo.2013.11.017. Epub 2014 Mar 11.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2008-005625-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
312042
Identifier Type: OTHER
Identifier Source: secondary_id
91781
Identifier Type: -
Identifier Source: org_study_id
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