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

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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Locations
Status
LocationsStatus
Locations

Investigative Site

West Palm Beach, United States, 33409

Status
Completed
 
Locations

Investigative Site

Metairie, United States, 70006

Status
Completed
 
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Investigative Site

New Brunswick, United States, 08901

Status
Completed
 
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Investigative Site

Idaho Falls, United States, 83406

Status
Completed
 
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Investigative Site

South Bend, United States, 46601

Status
Completed
 
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Investigative Site

Santa Monica, United States, 90404

Status
Completed
 
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Investigative Site

St. Louis, United States, 63141

Status
Completed
 
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Investigative Site

Jacksonville, United States, 32207

Status
Completed
 
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Investigative Site

San Diego, United States, 92108

Status
Completed
 
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Investigative Site

Boise, United States, 83712

Status
Completed
 
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Investigative Site

Las Vegas, United States, 89128

Status
Completed
 
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Investigative Site

Decatur, United States, 30034

Status
Completed
 
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Investigative Site

Columbus, United States, 43213

Status
Completed
 
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Investigative Site

La Crosse, United States, 54601

Status
Completed
 
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Investigative Site

Clearwater, United States, 33759

Status
Completed
 
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Investigative Site

Littleton, United States, 80127

Status
Completed
 
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Investigative Site

Encinitas, United States, 92024

Status
Completed
 
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Investigative Site

Portland, United States, 97239-3011

Status
Completed
 
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Investigative Site

Chesterfield, United States, 63017

Status
Completed
 
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Investigative Site

Winston-Salem, United States, 27103

Status
Completed
 
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Investigative Site

Glendale, United States, 85304

Status
Completed
 
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Investigative Site

Fishers, United States, 46037

Status
Completed
 
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Investigative Site

Philadelphia, United States, 19114

Status
Completed
 
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Investigative Site

Lincoln, United States, 68510

Status
Completed
 
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Investigative Site

Phoenix, United States, 85032

Status
Completed
 
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Investigative Site

Houston, United States, 77054

Status
Completed
 
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Investigative Site

Bristol, United States, 37620

Status
Completed
 
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Investigative Site

Cincinnati, United States, 45246

Status
Completed
 
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Investigative Site

Memphis, United States, 38120

Status
Completed
 
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Investigative Site

Denver, United States, 80218

Status
Completed
 
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Investigative Site

Boise, United States, 83702

Status
Completed
 
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Investigative Site

Indianapolis, United States, 46217

Status
Completed
 
Locations

Investigative Site

Shawinigan, Canada, G9N 2H6

Status
Completed
 
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Investigative Site

Hamilton, Canada, L8M 1K7

Status
Completed
 
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Investigative Site

Woodstock, Canada, N4S 5P5

Status
Completed
 
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Investigative Site

Pointe-Claire, Canada, H9R 4S3

Status
Completed
 
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Investigative Site

Downsview, Canada, M3J 1N2

Status
Completed
 
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Investigative Site

Halifax, Canada, B3K 5R3

Status
Completed
 
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Investigative Site

Sarnia, Canada, N7T 4X3

Status
Completed
 
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Investigative Site

Regina, Canada, S4P 3X1

Status
Completed
 
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Investigative Site

Bathurst, Canada, E2A 4Z9

Status
Completed
 
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Investigative Site

Charlottetown, Canada, C1A 5Y9

Status
Completed
 
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Investigative Site

Spokane, United States, 99207

Status
Completed
 
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Investigative Site

Denver, United States, 80206

Status
Completed
 
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Investigative Site

Ottawa, Canada, K1H 7W9

Status
Completed
 
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Investigative Site

Newmarket, Canada, L3Y 5G8

Status
Completed
 
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Investigative Site

Langley, Canada, V3A 4H9

Status
Completed
 
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Investigative Site

Saskatoon, Canada, S7K 7H9

Status
Completed
 
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Investigative Site

Corunna, Canada, N0N 1G0

Status
Completed
 
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Investigative Site

Quebec, Canada, G3K 2P8

Status
Completed
 
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Investigative Site

Toronto, Canada, M4S 1Y2

Status
Completed
 
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Investigative Site

Saskatoon, Canada, S7H 5M3

Status
Completed
 
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Investigative Site

Drummondville, Canada, J2B 7T1

Status
Completed
 
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Investigative Site

Pointe-Claire, Canada, H9R 3J1

Status
Completed
 
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Investigative Site

Hamilton, Canada, L8L 5G8

Status
Completed
 
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Investigative Site

Mirabel, Canada, J7J 2K8

Status
Completed
 
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Investigative Site

Ste-Foy, Canada, G1V 4X7

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M9W 4L6

Status
Completed
 
Locations

Investigative Site

St. John's, Canada, A1A 3R5

Status
Completed
 

Trial Design