To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

Condition(s) targeted: Contraceptive

Intervention: Qlaira (BAY86-5027, SH T00658ID) (Drug); Ortho Tri Cyclen Lo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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 LNG, NGM, or norethindrone/norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such of pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.

Official title: 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.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The change of pelvic pain (stratum 1) or the change of headache (stratum 2) as determined by the change of average VAS (Visual Analog Scale) during cycle days 22 to 28

Secondary outcome:

Change in VAS of the hormone withdrawal-associated symptoms pelvic pain or headache

Rescue medication consumption

Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting)

Prevalence of individual hormone-related symptoms

Prevalence of individual hormone-related symptoms during hormone-free interval

Bleeding pattern and cycle control

QoL Questionnaires

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

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 [Section 11. 3]

- 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)

- 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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Quebec G2B 5S1, Canada; Recruiting

Montgomery, Alabama 36116, United States; Not yet recruiting

Glendale, Arizona 85304, United States; Recruiting

Phoenix, Arizona 85032, United States; Recruiting

Langley, British Columbia V3A 4H9, Canada; Recruiting

North Vancouver, British Columbia V7N 4M2, Canada; Not yet recruiting

North Vancouver, British Columbia V7M 2H5, Canada; Not yet recruiting

Pacific Palisades, California 90272, United States; Recruiting

Encinitas, California 92024, United States; Recruiting

San Diego, California 92108, United States; Recruiting

Irvine, California 92618-3603, United States; Not yet recruiting

Littleton, Colorado 80127, United States; Recruiting

Littleton, Colorado 80122, United States; Not yet recruiting

Denver, Colorado 80202, United States; Recruiting

Denver, Colorado 80206, United States; Recruiting

West Palm Beach, Florida 33409, United States; Recruiting

Clearwater, Florida 33759, United States; Recruiting

Jacksonville, Florida 32209, United States; Recruiting

Daytona Beach, Florida 32114, United States; Not yet recruiting

Decatur, Georgia 30034, United States; Recruiting

Idaho Falls, Idaho 83406, United States; Recruiting

Boise, Idaho 83712, United States; Recruiting

Boise, Idaho 83702, United States; Recruiting

South Bend, Indiana 46601, United States; Recruiting

Fishers, Indiana 46037, United States; Recruiting

Indianapolis, Indiana 46217, United States; Recruiting

Indianapolis, Indiana 46220, United States; Not yet recruiting

Metairie, Louisiana 70006, United States; Recruiting

St. Louis, Missouri 63141, United States; Recruiting

Chesterfield, Missouri 63017, United States; Recruiting

Fremont, Nebraska 68025, United States; Not yet recruiting

Lincoln, Nebraska 68510, United States; Recruiting

Las Vegas, Nevada 89128, United States; Recruiting

Bathurst, New Brunswick E2A 4X7, Canada; Recruiting

New Brunswick, New Jersey 08901, United States; Recruiting

Moorestown, New Jersey 08057, United States; Not yet recruiting

St. John's, Newfoundland and Labrador A1A 3R5, Canada; Recruiting

Winston-Salem, North Carolina 27103, United States; Recruiting

Winston-Salem, North Carolina 27103, United States; Not yet recruiting

Halifax, Nova Scotia B3J 3G9, Canada; Not yet recruiting

Halifax, Nova Scotia B3K 5R3, Canada; Recruiting

Columbus, Ohio 43213, United States; Recruiting

Cincinnati, Ohio 45246, United States; Recruiting

Ottawa, Ontario K1H 7W9, Canada; Not yet recruiting

Hamilton, Ontario L8M 1K7, Canada; Recruiting

Woodstock, Ontario N4S 5P5, Canada; Recruiting

Newmarket, Ontario L3Y 5G8, Canada; Recruiting

Downsview, Ontario M3J 1N2, Canada; Recruiting

Sarnia, Ontario N7T 4X3, Canada; Recruiting

Corunna, Ontario N0N 1G0, Canada; Recruiting

Toronto, Ontario M4S1Y2, Canada; Recruiting

Hamilton, Ontario L8L 5G8, Canada; Recruiting

Toronto, Ontario M9W 4L6, Canada; Recruiting

Portland, Oregon 97239, United States; Recruiting

Pittsburgh, Pennsylvania 15241, United States; Not yet recruiting

Philadelphia, Pennsylvania 19114, United States; Recruiting

Charlottetown, Prince Edward Island C1A 5Y9, Canada; Recruiting

Shawinigan, Quebec G9N 2H6, Canada; Recruiting

Pointe-Claire, Quebec H9R 4S3, Canada; Recruiting

Montreal, Quebec H4P 2S4, Canada; Not yet recruiting

Drummondville, Quebec J2B 1H8, Canada; Recruiting

Pointe-Claire, Quebec H9R 3J1, Canada; Recruiting

Mirabel, Quebec J7J 1L2, Canada; Recruiting

Ste-Foy, Quebec GIV 4X7, Canada; Recruiting

Saskatoon, Saskatchewan S7K 7H9, Canada; Completed

Regina, Saskatchewan S4P 3X1, Canada; Recruiting

Saskatoon, Saskatchewan S7H 0W6, Canada; Recruiting

Memphis, Tennessee 38120, United States; Recruiting

Bristol, Tennessee 37620, United States; Recruiting

Houston, Texas 77054, United States; Recruiting

Spokane, Washington 99207, United States; Recruiting

La Crosse, Wisconsin 54601, United States; Recruiting

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Starting date: September 2008
Ending date: February 2011
Last updated: October 9, 2009