Clinical trial NCT00754065: To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Oral contraceptive
Estradiol valerate and dienogest
EV/DNG
comparative tolerability
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 409
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Safety issues are addressed in the Adverse Events section.

Eligibility 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)
* 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

Primary outcomes:
measure: 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
timeFrame: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
Secondary outcomes:
measure: The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication
timeFrame: From Baseline to Cycle 6 (28 days per Cycle)
measure: The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication
timeFrame: From Baseline to Cycle 13 (28 days per Cycle)
measure: 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
timeFrame: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
measure: 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
timeFrame: Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)
measure: 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
timeFrame: Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)
measure: 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
timeFrame: Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)
measure: 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
timeFrame: Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)
measure: Number of Days With Bleeding or Spotting in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Number of Days With Bleeding or Spotting in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Number of Days With Bleeding or Spotting in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Number of Days With Bleeding or Spotting in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Number of Bleeding / Spotting Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Number of Bleeding / Spotting Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Number of Bleeding / Spotting Episodes in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Number of Bleeding / Spotting Episodes in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Mean Length of Bleeding / Spotting Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Mean Length of Bleeding / Spotting Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Mean Length of Bleeding / Spotting Episodes in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Mean Length of Bleeding / Spotting Episodes in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Maximum Length of Bleeding / Spotting Episodes in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Maximum Length of Bleeding / Spotting Episodes in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Number of Days With Spotting-only in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Number of Days With Spotting-only in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Number of Days With Spotting-only in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Number of Days With Spotting-only in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Number of Spotting-only Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Number of Spotting-only Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Number of Spotting-only Episodes in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Number of Spotting-only Episodes in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Mean Length of Spotting-only Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Mean Length of Spotting-only Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Mean Length of Spotting-only Episodes in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Mean Length of Spotting-only Episodes in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Maximum Length of Spotting-only Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Maximum Length of Spotting-only Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Maximum Length of Spotting-only Episodes in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Maximum Length of Spotting-only Episodes in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1
timeFrame: From Day 1 to Day 90
measure: Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
timeFrame: From Day 91 to Day 180
measure: Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3
timeFrame: From Day 181 to Day 270
measure: Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4
timeFrame: From Day 271 to Day 360
measure: Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Length of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Length of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Length of Withdrawal Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Length of Withdrawal Bleeding Episodes at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Onset of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Onset of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Onset of Withdrawal Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Onset of Withdrawal Bleeding Episodes at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Episodes at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Maximum Length of Intracyclic Bleeding Episodes at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Days at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Days at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Days at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Number of Intracyclic Bleeding Days at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
timeFrame: At Cycle 1 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
timeFrame: At Cycle 3 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6
timeFrame: Cycles 2 to 6 (28 days per Cycle)
measure: Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13
timeFrame: Cycles 2 to 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
timeFrame: Baseline up to Cycle 6 (28 days per Cycle)
measure: Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
timeFrame: Baseline up to Cycle 13 (28 days per Cycle)
measure: Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
measure: Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
timeFrame: At Cycle 6 (28 days per Cycle)
measure: Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13
timeFrame: At Cycle 13 (28 days per Cycle)
Other outcomes:
measure: Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
timeFrame: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
measure: The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6
timeFrame: Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)
Locations:
city: Independence
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Encinitas
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Boise
country: United States
state: Idaho
city: Idaho Falls
country: United States
state: Idaho
city: Fishers
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Metairie
country: United States
state: Louisiana
city: Chesterfield
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: New Brunswick
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: La Crosse
country: United States
state: Wisconsin
city: Langley
country: Canada
state: British Columbia
city: Bathurst
country: Canada
state: New Brunswick
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Corunna
country: Canada
state: Ontario
city: Downsview
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Woodstock
country: Canada
state: Ontario
city: Charlottetown
country: Canada
state: Prince Edward Island
city: Drummondville
country: Canada
state: Quebec
city: Mirabel
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Shawinigan
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Saskatoon
country: Canada
state: Saskatchewan
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Jensen JT, Parke S, Mellinger U, Serrani M, Mabey RG Jr. Hormone withdrawal-associated symptoms: comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate. Eur J Contracept Reprod Health Care. 2013 Aug;18(4):274-83. doi: 10.3109/13625187.2013.785516. Epub 2013 May 2.