check_circleStudy Completed

Contraception

Bayer Identifier:

13108

ClinicalTrials.gov Identifier:

NCT00754065

EudraCT Number:

Not Available

EU CT Number:

Not Available
To compare SH T00658ID over Ortho Tri-Cyclen Lo (US/Canada)

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.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years
  • - 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

Trial summary

Enrollment Goal
409
Trial Dates
September 2008 - May 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
West Palm Beach, 33409, United States
Completed
Metairie, 70006, United States
Completed
New Brunswick, 08901, United States
Completed
Idaho Falls, 83406, United States
Completed
South Bend, 46601, United States
Completed
Santa Monica, 90404, United States
Completed
St. Louis, 63141, United States
Completed
Jacksonville, 32207, United States
Completed
San Diego, 92108, United States
Completed
Boise, 83712, United States
Completed
Las Vegas, 89128, United States
Completed
Decatur, 30034, United States
Completed
Columbus, 43213, United States
Completed
La Crosse, 54601, United States
Completed
Clearwater, 33759, United States
Completed
Littleton, 80127, United States
Completed
Encinitas, 92024, United States
Completed
Portland, 97239-3011, United States
Completed
Chesterfield, 63017, United States
Completed
Winston-Salem, 94925, United States
Completed
Independence, 94925, United States
Completed
Fishers, 46037, United States
Completed
Philadelphia, 19114, United States
Completed
Lincoln, 68510, United States
Completed
Phoenix, 85032, United States
Completed
Houston, 77054, United States
Completed
Bristol, 37620, United States
Completed
Cincinnati, 45246, United States
Completed
Memphis, 38120, United States
Completed
Denver, 80218, United States
Completed
Boise, 83702, United States
Completed
Indianapolis, 46217, United States
Completed
Shawinigan, G9N 2H6, Canada
Completed
Hamilton, L8M 1K7, Canada
Completed
Woodstock, N4S 5P5, Canada
Completed
Pointe-Claire, H9R 4S3, Canada
Completed
Downsview, M3J 1N2, Canada
Completed
Halifax, B3K 5R3, Canada
Completed
Sarnia, N7T 4X3, Canada
Completed
Regina, S4P 3X1, Canada
Completed
Bathurst, E2A 4Z9, Canada
Completed
Charlottetown, C1A 5Y9, Canada
Completed
Spokane, 99207, United States
Completed
Denver, 80206, United States
Completed
Ottawa, K1H 7W9, Canada
Completed
Newmarket, L3Y 5G8, Canada
Completed
Langley, V3A 4H9, Canada
Completed
Saskatoon, S7K 7H9, Canada
Completed
Corunna, N0N 1G0, Canada
Completed
Quebec, G3K 2P8, Canada
Completed
Toronto, M4S 1Y2, Canada
Completed
Saskatoon, S7H 5M3, Canada
Completed
Drummondville, J2B 7T1, Canada
Completed
Pointe-Claire, H9R 3J1, Canada
Completed
Hamilton, L8L 5G8, Canada
Completed
Mirabel, J7J 2K8, Canada
Completed
Ste-Foy, G1V 4X7, Canada
Completed
Toronto, M9W 4L6, Canada
Completed
St. John's, A1A 3R5, Canada

Primary Outcome

  • The change in average of the 3 highest visual analog scale (VAS) values of the hormone withdrawal-associated symptoms pelvic pain or headache during cycle Days 22 to 28 from Baseline to Cycle 6
    date_rangeTime Frame:
    Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • The change from Baseline to Cycle 6 in the number of ibuprofen tablets used as rescue medication
    date_rangeTime Frame:
    From Baseline to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • The change from Baseline to Cycle 13 in the number of ibuprofen tablets used as rescue medication
    date_rangeTime Frame:
    From Baseline to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline to Cycle 6 in the number of days with at least moderate pain/intensity of other hormone-related symptoms during cycle Days 22-28
    date_rangeTime Frame:
    Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline to Cycle 13 in the number of days with at least moderate pain/intensity of other hormone-related symptoms during cycle Days 22-28
    date_rangeTime Frame:
    Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline to Cycle 6 in the number of days with at least moderate pain/intensity of individual hormone-related symptoms during cycle Days 1-21
    date_rangeTime Frame:
    Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline to Cycle 13 in the number of days with at least moderate pain/intensity of individual hormone-related symptoms during cycle Days 1-21
    date_rangeTime Frame:
    Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline to Cycle 6 in the number of days with at least moderate pain/intensity of individual hormone-related symptoms during the hormone-free interval cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM
    date_rangeTime Frame:
    From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline to Cycle 13 in the number of days with at least moderate pain/intensity of individual hormone-related symptoms during the hormone-free interval cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM
    date_rangeTime Frame:
    From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline to Cycle 3 in the average of the three highest VAS values of the hormone withdrawal-associated symptoms pelvic pain or headache during cycle Days 22 to 28
    date_rangeTime Frame:
    Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline to Cycle 13 in the average of the three highest VAS values of the hormone withdrawal-associated symptoms pelvic pain or headache during cycle Days 22 to 28
    date_rangeTime Frame:
    Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with bleeding or spotting in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with bleeding or spotting in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with bleeding or spotting in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with bleeding or spotting in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting episodes in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting episodes in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of bleeding / spotting episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of bleeding / spotting episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of bleeding / spotting episodes in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of bleeding / spotting episodes in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of bleeding / spotting episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of bleeding / spotting episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of bleeding / spotting episodes in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of bleeding / spotting episodes in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest bleeding / spotting episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest bleeding / spotting episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest bleeding / spotting episodes in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest bleeding / spotting episodes in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with spotting-only in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with spotting-only in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with spotting-only in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with spotting-only in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Number of spotting-only episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of spotting-only episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Number of spotting-only episodes in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Number of spotting-only episodes in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of spotting-only episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of spotting-only episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of spotting-only episodes in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of spotting-only episodes in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of spotting-only episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of spotting-only episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of spotting-only episodes in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of spotting-only episodes in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest spotting-only episodes in reference period 1
    date_rangeTime Frame:
    From Day 1 to Day 90
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest spotting-only episodes in reference period 2
    date_rangeTime Frame:
    From Day 91 to Day 180
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest spotting-only episodes in reference period 3
    date_rangeTime Frame:
    From Day 181 to Day 270
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest spotting-only episodes in reference period 4
    date_rangeTime Frame:
    From Day 271 to Day 360
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with / without withdrawal bleeding at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with / without withdrawal bleeding at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with / without withdrawal bleeding at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with / without withdrawal bleeding at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Length of withdrawal bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Length of withdrawal bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Length of withdrawal bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Length of withdrawal bleeding episodes at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum intensity of withdrawal bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum intensity of withdrawal bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum intensity of withdrawal bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum intensity of withdrawal bleeding episodes at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Onset of withdrawal bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Onset of withdrawal bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Onset of withdrawal bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Onset of withdrawal bleeding episodes at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with presence or absence of intracyclic bleeding at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with presence or absence of intracyclic bleeding at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with presence or absence of intracyclic bleeding at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with presence or absence of intracyclic bleeding at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding episodes at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of intracyclic bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of intracyclic bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of intracyclic bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of intracyclic bleeding episodes at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding days at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding days at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding days at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding days at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 1
    date_rangeTime Frame:
    At Cycle 1 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 3
    date_rangeTime Frame:
    At Cycle 3 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with at least 1 intracyclic bleeding episode at Cycles 2 to 6
    date_rangeTime Frame:
    Cycles 2 to 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with at least 1 intracyclic bleeding episode at Cycles 2 to 13
    date_rangeTime Frame:
    Cycles 2 to 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – physical health
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – physical health
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – participant feeling
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – participant feeling
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – work
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – work
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – household duties
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – household duties
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – school/course work
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – school/course work
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – leisure time activities
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – leisure time activities
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – social relationship
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – social relationship
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – general activities
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – general activities
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – item satisfaction
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – item satisfaction
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – overall life satisfaction and contentment
    date_rangeTime Frame:
    Baseline up to Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – overall life satisfaction and contentment
    date_rangeTime Frame:
    Baseline up to Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with improvement in the investigator's assessment in Clinical Global Impression (CGI) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with improvement in the investigator's assessment in Clinical Global Impression (CGI) at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with improvement in the participant's assessment in Clinical Global Impression (CGI) at Cycle 6
    date_rangeTime Frame:
    At Cycle 6 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with improvement in the participant's assessment in Clinical Global Impression (CGI) at Cycle 13
    date_rangeTime Frame:
    At Cycle 13 (28 days per Cycle)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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

Additional Information

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