Trial Condition(s):
Contraception
To compare SH T00658ID over Ortho Tri-Cyclen Lo (US/Canada)
Bayer Identifier:
13108
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Comprehensive Clinical Trials West Palm Beach, United States, 33409 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trials Management, LLC Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Robert Wood Johnson Medical School New Brunswick, United States, 08901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rosemark Clinical Research Idaho Falls, United States, 83406 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northern Indiana Womens Heatlh Research, Inc. South Bend, United States, 46601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Blue Hill Medical Group Santa Monica, United States, 90404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Ballas OB-GYN, Inc. St. Louis, United States, 63141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Florida College of Medicine Jacksonville, United States, 32207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Women's Clinic Boise, United States, 83712 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. R. Garn Mabey, MD Las Vegas, United States, 89128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soapstone Center for Clinical Research Decatur, United States, 30034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbus Center for Women's Health Research Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Wisconsin - La Crosse La Crosse, United States, 54601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Medical Research Group, LLC Clearwater, United States, 33759 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Altitude Family Medicine, PC Littleton, United States, 80127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pacific Coast Research Center Inc. Encinitas, United States, 92024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Health and Science University Portland, United States, 97239-3011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PPS Clinical Research, LLC Chesterfield, United States, 63017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lyndhurst Gynecologic Associates Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Precision Trials, LLC Glendale, United States, 85304 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Internal Medicine and Pediatrics Fishers, United States, 46037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Clinic of Lincoln, PC Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Precision Trials Phoenix, United States, 85032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Woman's Hospital of Texas Houston, United States, 77054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Holston Medical Group Bristol, United States, 37620 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Associates in OB-GYN, Inc. Cincinnati, United States, 45246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Adam Patterson OB-GYN Memphis, United States, 38120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Downtown Women's Healthcare Denver, United States, 80218 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Associates Boise, United States, 83702 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations First Care Family Medicine Indianapolis, United States, 46217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique de Gynecologie Shawinigan, Canada, G9N 2H6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hamilton Medical Research Group Hamilton, Canada, L8M 1K7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Devonshire Clinical Research, Inc. Woodstock, Canada, N4S 5P5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kells Medical Research Group, Inc. Pointe-Claire, Canada, H9R 4S3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Ivor Teitelbaum, MD Downsview, Canada, M3J 1N2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MSHJ Research Associates Halifax, Canada, B3K 5R3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations London Road Diagnostic Centre Sarnia, Canada, N7T 4X3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regina Medical Centre Regina, Canada, S4P 3X1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maritimes Research Center Bathurst, Canada, E2A 4Z9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Island Clinical Trials Charlottetown, Canada, C1A 5Y9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Spokane Women’s Health Research Spokane, United States, 99207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cherry Creek Family Practice Denver, United States, 80206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Hospital-Riverside Campus Ottawa, Canada, K1H 7W9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Sami Henein, MD Newmarket, Canada, L3Y 5G8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Glover Medical Clinic Langley, Canada, V3A 4H9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lenore Center Medical Clinic Saskatoon, Canada, S7K 7H9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Corunna Medical Research Centre Corunna, Canada, N0N 1G0 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ALPHA Recherche Clinique Quebec, Canada, G3K 2P8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prime Health Research Toronto, Canada, M4S 1Y2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Acadia Medical Centre Saskatoon, Canada, S7H 5M3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rhodin Recherche Clinique Drummondville, Canada, J2B 7T1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dynamik Clinical Research Group Pointe-Claire, Canada, H9R 3J1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Allen S. Greenspoon, MD Hamilton, Canada, L8L 5G8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Omnispec Recherche Clinique Inc. Mirabel, Canada, J7J 1L2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Médicale des Campus Ste-Foy, Canada, G1V 4X7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Manna Research Toronto, Canada, M9W 4L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations White Hills Medical Clinic St. John's, Canada, A1A 3R5 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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 6Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
Secondary Outcome
- The change from Baseline to Cycle 6 in the number of ibuprofen tablets used as rescue medicationTimeframe: From Baseline to Cycle 6 (28 days per Cycle)
- The change from Baseline to Cycle 13 in the number of ibuprofen tablets used as rescue medicationTimeframe: From Baseline to Cycle 13 (28 days per Cycle)
- 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 22-28Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
- 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 22-28Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)
- 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 1-21Timeframe: Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)
- 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 1-21Timeframe: Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)
- 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/NGMTimeframe: 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)
- 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/NGMTimeframe: 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)
- 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 28Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)
- 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 28Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)
- Number of days with bleeding or spotting in reference period 1Timeframe: From Day 1 to Day 90
- Number of days with bleeding or spotting in reference period 2Timeframe: From Day 91 to Day 180
- Number of days with bleeding or spotting in reference period 3Timeframe: From Day 181 to Day 270
- Number of days with bleeding or spotting in reference period 4Timeframe: From Day 271 to Day 360
- Number of bleeding / spotting episodes in reference period 1Timeframe: From Day 1 to Day 90
- Number of bleeding / spotting episodes in reference period 2Timeframe: From Day 91 to Day 180
- Number of bleeding / spotting episodes in reference period 3Timeframe: From Day 181 to Day 270
- Number of bleeding / spotting episodes in reference period 4Timeframe: From Day 271 to Day 360
- Mean length of bleeding / spotting episodes in reference period 1Timeframe: From Day 1 to Day 90
- Mean length of bleeding / spotting episodes in reference period 2Timeframe: From Day 91 to Day 180
- Mean length of bleeding / spotting episodes in reference period 3Timeframe: From Day 181 to Day 270
- Mean length of bleeding / spotting episodes in reference period 4Timeframe: From Day 271 to Day 360
- Maximum length of bleeding / spotting episodes in reference period 1Timeframe: From Day 1 to Day 90
- Maximum length of bleeding / spotting episodes in reference period 2Timeframe: From Day 91 to Day 180
- Maximum length of bleeding / spotting episodes in reference period 3Timeframe: From Day 181 to Day 270
- Maximum length of bleeding / spotting episodes in reference period 4Timeframe: From Day 271 to Day 360
- Difference in duration between longest and shortest bleeding / spotting episodes in reference period 1Timeframe: From Day 1 to Day 90
- Difference in duration between longest and shortest bleeding / spotting episodes in reference period 2Timeframe: From Day 91 to Day 180
- Difference in duration between longest and shortest bleeding / spotting episodes in reference period 3Timeframe: From Day 181 to Day 270
- Difference in duration between longest and shortest bleeding / spotting episodes in reference period 4Timeframe: From Day 271 to Day 360
- Number of days with spotting-only in reference period 1Timeframe: From Day 1 to Day 90
- Number of days with spotting-only in reference period 2Timeframe: From Day 91 to Day 180
- Number of days with spotting-only in reference period 3Timeframe: From Day 181 to Day 270
- Number of days with spotting-only in reference period 4Timeframe: From Day 271 to Day 360
- Number of spotting-only episodes in reference period 1Timeframe: From Day 1 to Day 90
- Number of spotting-only episodes in reference period 2Timeframe: From Day 91 to Day 180
- Number of spotting-only episodes in reference period 3Timeframe: From Day 181 to Day 270
- Number of spotting-only episodes in reference period 4Timeframe: From Day 271 to Day 360
- Mean length of spotting-only episodes in reference period 1Timeframe: From Day 1 to Day 90
- Mean length of spotting-only episodes in reference period 2Timeframe: From Day 91 to Day 180
- Mean length of spotting-only episodes in reference period 3Timeframe: From Day 181 to Day 270
- Mean length of spotting-only episodes in reference period 4Timeframe: From Day 271 to Day 360
- Maximum length of spotting-only episodes in reference period 1Timeframe: From Day 1 to Day 90
- Maximum length of spotting-only episodes in reference period 2Timeframe: From Day 91 to Day 180
- Maximum length of spotting-only episodes in reference period 3Timeframe: From Day 181 to Day 270
- Maximum length of spotting-only episodes in reference period 4Timeframe: From Day 271 to Day 360
- Difference in duration between longest and shortest spotting-only episodes in reference period 1Timeframe: From Day 1 to Day 90
- Difference in duration between longest and shortest spotting-only episodes in reference period 2Timeframe: From Day 91 to Day 180
- Difference in duration between longest and shortest spotting-only episodes in reference period 3Timeframe: From Day 181 to Day 270
- Difference in duration between longest and shortest spotting-only episodes in reference period 4Timeframe: From Day 271 to Day 360
- Percentage of participants with / without withdrawal bleeding at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Percentage of participants with / without withdrawal bleeding at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Percentage of participants with / without withdrawal bleeding at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Percentage of participants with / without withdrawal bleeding at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Length of withdrawal bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Length of withdrawal bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Length of withdrawal bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Length of withdrawal bleeding episodes at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Maximum intensity of withdrawal bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Maximum intensity of withdrawal bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Maximum intensity of withdrawal bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Maximum intensity of withdrawal bleeding episodes at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Onset of withdrawal bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Onset of withdrawal bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Onset of withdrawal bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Onset of withdrawal bleeding episodes at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Percentage of participants with presence or absence of intracyclic bleeding at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Percentage of participants with presence or absence of intracyclic bleeding at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Percentage of participants with presence or absence of intracyclic bleeding at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Percentage of participants with presence or absence of intracyclic bleeding at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Number of intracyclic bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Number of intracyclic bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Number of intracyclic bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Number of intracyclic bleeding episodes at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Maximum length of intracyclic bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Maximum length of intracyclic bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Maximum length of intracyclic bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Maximum length of intracyclic bleeding episodes at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Number of intracyclic bleeding days at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Number of intracyclic bleeding days at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Number of intracyclic bleeding days at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Number of intracyclic bleeding days at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 1Timeframe: At Cycle 1 (28 days per Cycle)
- Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 3Timeframe: At Cycle 3 (28 days per Cycle)
- Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Percentage of participants by maximum intensity of intracyclic bleeding episodes at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Percentage of participants with at least 1 intracyclic bleeding episode at Cycles 2 to 6Timeframe: Cycles 2 to 6 (28 days per Cycle)
- Percentage of participants with at least 1 intracyclic bleeding episode at Cycles 2 to 13Timeframe: Cycles 2 to 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – physical healthTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – physical healthTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – participant feelingTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – participant feelingTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – workTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – workTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – household dutiesTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – household dutiesTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – school/course workTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – school/course workTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – leisure time activitiesTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – leisure time activitiesTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – social relationshipTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – social relationshipTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – general activitiesTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – general activitiesTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – item satisfactionTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – item satisfactionTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Mean change from Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – overall life satisfaction and contentmentTimeframe: Baseline up to Cycle 6 (28 days per Cycle)
- Mean change from Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – overall life satisfaction and contentmentTimeframe: Baseline up to Cycle 13 (28 days per Cycle)
- Percentage of participants with improvement in the investigator's assessment in Clinical Global Impression (CGI) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Percentage of participants with improvement in the investigator's assessment in Clinical Global Impression (CGI) at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
- Percentage of participants with improvement in the participant's assessment in Clinical Global Impression (CGI) at Cycle 6Timeframe: At Cycle 6 (28 days per Cycle)
- Percentage of participants with improvement in the participant's assessment in Clinical Global Impression (CGI) at Cycle 13Timeframe: At Cycle 13 (28 days per Cycle)
Additional Information
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