Trial Condition(s):
To compare SH T00658ID over Ortho Tri-Cyclen Lo (US/Canada)
13108
Not Available
Not Available
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.
- 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
- 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
Locations | |
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Locations Investigative Site West Palm Beach, United States, 33409 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Brunswick, United States, 08901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Idaho Falls, United States, 83406 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site South Bend, United States, 46601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santa Monica, United States, 90404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boise, United States, 83712 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Decatur, United States, 30034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Crosse, United States, 54601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clearwater, United States, 33759 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Littleton, United States, 80127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Encinitas, United States, 92024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239-3011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United States, 63017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glendale, United States, 85304 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fishers, United States, 46037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Phoenix, United States, 85032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bristol, United States, 37620 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Memphis, United States, 38120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Denver, United States, 80218 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boise, United States, 83702 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Indianapolis, United States, 46217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shawinigan, Canada, G9N 2H6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamilton, Canada, L8M 1K7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woodstock, Canada, N4S 5P5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pointe-Claire, Canada, H9R 4S3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Downsview, Canada, M3J 1N2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halifax, Canada, B3K 5R3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sarnia, Canada, N7T 4X3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Regina, Canada, S4P 3X1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bathurst, Canada, E2A 4Z9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charlottetown, Canada, C1A 5Y9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spokane, United States, 99207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Denver, United States, 80206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1H 7W9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newmarket, Canada, L3Y 5G8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Langley, Canada, V3A 4H9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saskatoon, Canada, S7K 7H9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Corunna, Canada, N0N 1G0 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quebec, Canada, G3K 2P8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M4S 1Y2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saskatoon, Canada, S7H 5M3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Drummondville, Canada, J2B 7T1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pointe-Claire, Canada, H9R 3J1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamilton, Canada, L8L 5G8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mirabel, Canada, J7J 2K8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ste-Foy, Canada, G1V 4X7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M9W 4L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. John's, Canada, A1A 3R5 | Contact Us: E-mail: [email protected] Phone: Not Available |
A multicenter, randomized, double-blind, active-controlled, parallel group, 2-arm study to show superiority of the oral contraceptive SH T00658ID over Ortho Tri-Cyclen Lo on hormone withdrawal-associated symptoms after 6 cycles of treatment.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2