To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
NCT ID: NCT00754065
Last Updated: 2024-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
409 participants
INTERVENTIONAL
2008-09-08
2011-05-10
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
DOUBLE
Study Groups
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Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo
Ortho Tri-Cyclen Lo
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Ortho Tri Cyclen Lo
Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo
Interventions
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Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo
Ortho Tri Cyclen Lo
Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1
* Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of \>/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction)
* Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS.
* Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator
Exclusion Criteria
* Body mass index (BMI) \>32 kg/m2
* Hypersensitivity to any of the study drug ingredients
* Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules
* Safety relevant laboratory values, provided by the central laboratory, outside inclusion range before start of treatment
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise)
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Any disease or condition that may worsen under hormonal treatment
* Undiagnosed abnormal genital bleeding
* Abuse of alcohol, drugs, or medicines (eg, laxatives)
* Other contraceptive methods
* Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
* Simultaneous 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
* Subject is a dependent person, eg: a family member or member of the Investigator's staff
* Inability to cooperate with the study procedures for any reason, including language comprehension, psychiatric illness, inability to get to the study site
18 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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Independence, Arizona, United States
Phoenix, Arizona, United States
Encinitas, California, United States
San Diego, California, United States
Santa Monica, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Littleton, Colorado, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
West Palm Beach, Florida, United States
Decatur, Georgia, United States
Boise, Idaho, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Fishers, Indiana, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Metairie, Louisiana, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
New Brunswick, New Jersey, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Bristol, Tennessee, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Spokane, Washington, United States
La Crosse, Wisconsin, United States
Langley, British Columbia, Canada
Bathurst, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Corunna, Ontario, Canada
Downsview, Ontario, Canada
Hamilton, Ontario, Canada
Hamilton, Ontario, Canada
Newmarket, Ontario, Canada
Ottawa, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Woodstock, Ontario, Canada
Charlottetown, Prince Edward Island, Canada
Drummondville, Quebec, Canada
Mirabel, Quebec, Canada
Pointe-Claire, Quebec, Canada
Pointe-Claire, Quebec, Canada
Shawinigan, Quebec, Canada
Ste-Foy, Quebec, Canada
Regina, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Québec, , Canada
Countries
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References
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Jensen JT, Parke S, Mellinger U, Serrani M, Mabey RG Jr. Hormone withdrawal-associated symptoms: comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate. Eur J Contracept Reprod Health Care. 2013 Aug;18(4):274-83. doi: 10.3109/13625187.2013.785516. Epub 2013 May 2.
Other Identifiers
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13108
Identifier Type: -
Identifier Source: org_study_id
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