Trial Condition(s):

Contraception

To compare SH T00658ID over Ortho Tri-Cyclen Lo (US/Canada)

Bayer Identifier:

13108

ClinicalTrials.gov Identifier:

NCT00754065

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.

Inclusion Criteria
- Signed and dated informed consent
 - 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
- Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment)
 - 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

Trial Summary

Enrollment Goal
409
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
Yes

Where to Participate

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Investigative Site

West Palm Beach, United States, 33409

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Metairie, United States, 70006

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New Brunswick, United States, 08901

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Idaho Falls, United States, 83406

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South Bend, United States, 46601

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Santa Monica, United States, 90404

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St. Louis, United States, 63141

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Jacksonville, United States, 32207

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San Diego, United States, 92108

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Boise, United States, 83712

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Las Vegas, United States, 89128

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Decatur, United States, 30034

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Columbus, United States, 43213

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La Crosse, United States, 54601

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Clearwater, United States, 33759

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Littleton, United States, 80127

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Encinitas, United States, 92024

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Portland, United States, 97239-3011

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Chesterfield, United States, 63017

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Winston-Salem, United States, 27103

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Glendale, United States, 85304

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Fishers, United States, 46037

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Philadelphia, United States, 19114

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Lincoln, United States, 68510

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Phoenix, United States, 85032

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Houston, United States, 77054

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Bristol, United States, 37620

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Cincinnati, United States, 45246

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Memphis, United States, 38120

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Denver, United States, 80218

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Boise, United States, 83702

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Indianapolis, United States, 46217

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Shawinigan, Canada, G9N 2H6

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Hamilton, Canada, L8M 1K7

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Woodstock, Canada, N4S 5P5

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Pointe-Claire, Canada, H9R 4S3

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Downsview, Canada, M3J 1N2

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Halifax, Canada, B3K 5R3

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Sarnia, Canada, N7T 4X3

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Regina, Canada, S4P 3X1

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Bathurst, Canada, E2A 4Z9

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Charlottetown, Canada, C1A 5Y9

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Spokane, United States, 99207

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Denver, United States, 80206

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Ottawa, Canada, K1H 7W9

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Newmarket, Canada, L3Y 5G8

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Langley, Canada, V3A 4H9

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Saskatoon, Canada, S7K 7H9

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Corunna, Canada, N0N 1G0

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Quebec, Canada, G3K 2P8

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Toronto, Canada, M4S 1Y2

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Saskatoon, Canada, S7H 5M3

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Drummondville, Canada, J2B 7T1

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Pointe-Claire, Canada, H9R 3J1

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Hamilton, Canada, L8L 5G8

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Mirabel, Canada, J7J 2K8

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Ste-Foy, Canada, G1V 4X7

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Toronto, Canada, M9W 4L6

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St. John's, Canada, A1A 3R5

Trial Design