AzTrials
AzTrials

ContraceptionPhase 3NCT00754065

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

A Phase 3 study testing Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) and Ortho Tri Cyclen Lo in people with Contraception, run by Bayer at 59 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) and Ortho Tri Cyclen Lo
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
409 participants
Where
59 sitesin 2 countries
Study dates
8 Sep 2008to 10 May 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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 locations and contacts

59 sites in 2 countries.

59 sites in 2 countries

United States34 sites

  • Study site

    Boise, Idaho, 83702

  • Study site

    Boise, Idaho, 83712

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Cincinnati, Ohio, 45246

  • Study site

    Clearwater, Florida, 33759

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Decatur, Georgia, 30034

  • Study site

    Denver, Colorado, 80206

  • Study site

    Denver, Colorado, 80218

  • Study site

    Encinitas, California, 92024

  • Study site

    Fishers, Indiana, 46037

  • Study site

    Houston, Texas, 77054

  • Study site

    Idaho Falls, Idaho, 83406

  • Study site

    Independence, Arizona, 94925

  • Study site

    Indianapolis, Indiana, 46217

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    La Crosse, Wisconsin, 54601

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Littleton, Colorado, 80127

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Portland, Oregon, 97239-3011

  • Study site

    San Diego, California, 92108

  • Study site

    Santa Monica, California, 90404

  • Study site

    South Bend, Indiana, 46601

  • Study site

    Spokane, Washington, 99207

  • Study site

    St Louis, Missouri, 63141

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Winston-Salem, North Carolina, 94925

Other trials in United States

Canada25 sites

  • Study site

    Bathurst, New Brunswick, E2A 4Z9

  • Study site

    Charlottetown, Prince Edward Island, C1A 5Y9

  • Study site

    Corunna, Ontario, N0N 1G0

  • Study site

    Downsview, Ontario, M3J 1N2

  • Study site

    Drummondville, Quebec, J2B 7T1

  • Study site

    Halifax, Nova Scotia, B3K 5R3

  • Study site

    Hamilton, Ontario, L8L 5G8

  • Study site

    Hamilton, Ontario, L8M 1K7

  • Study site

    Langley, British Columbia, V3A 4H9

  • Study site

    Mirabel, Quebec, J7J 2K8

  • Study site

    Newmarket, Ontario, L3Y 5G8

  • Study site

    Ottawa, Ontario, K1H 7W9

  • Study site

    Pointe-Claire, Quebec, H9R 3J1

  • Study site

    Pointe-Claire, Quebec, H9R 4S3

  • Study site

    Québec, G3K 2P8

  • Study site

    Regina, Saskatchewan, S4P 3X1

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

    Saskatoon, Saskatchewan, S7H 5M3

  • Study site

    Saskatoon, Saskatchewan, S7K 7H9

  • Study site

    Shawinigan, Quebec, G9N 2H6

  • Study site

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

  • Study site

    Ste-Foy, Quebec, G1V 4X7

  • Study site

    Toronto, Ontario, M4S 1Y2

  • Study site

    Toronto, Ontario, M9W 4L6

  • Study site

    Woodstock, Ontario, N4S 5P5

Other trials in Canada

About this study

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.

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.

Read the detailed description

Safety issues are addressed in the Adverse Events section.

Conditions
Contraception
Being tested
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Ortho Tri Cyclen Lo
Keywords
Oral contraceptive, Estradiol valerate and dienogest, EV/DNG, comparative tolerability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)Drug

    Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo

  • Ortho Tri Cyclen LoDrug

    Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo

Study groups in NCT00754065
Study groupRoleWhat they receive
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)ExperimentalDaily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Receives: Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Ortho Tri-Cyclen LoActive comparatorDaily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Receives: Drug: Ortho Tri Cyclen Lo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

    Measured: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

Secondary outcomes (114)

  1. The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication

    Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.

    Measured: From Baseline to Cycle 6 (28 days per Cycle)

  2. The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication

    Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.

    Measured: From Baseline to Cycle 13 (28 days per Cycle)

  3. 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

    Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).

    Measured: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

  4. 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

    Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).

    Measured: Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)

  5. 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

    Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).

    Measured: Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)

  6. 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

    Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).

    Measured: Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)

  7. 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

    Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.

    Measured: 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)

  8. 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

    Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.

    Measured: 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)

  9. 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

    Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

    Measured: Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)

  10. 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

    Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

    Measured: Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)

  11. Number of Days With Bleeding or Spotting in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

    Measured: From Day 1 to Day 90

  12. Number of Days With Bleeding or Spotting in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

    Measured: From Day 91 to Day 180

  13. Number of Days With Bleeding or Spotting in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

    Measured: From Day 181 to Day 270

  14. Number of Days With Bleeding or Spotting in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

    Measured: From Day 271 to Day 360

  15. Number of Bleeding / Spotting Episodes in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)

    Measured: From Day 1 to Day 90

  16. Number of Bleeding / Spotting Episodes in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)

    Measured: From Day 91 to Day 180

  17. Number of Bleeding / Spotting Episodes in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)

    Measured: From Day 181 to Day 270

  18. Number of Bleeding / Spotting Episodes in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)

    Measured: From Day 271 to Day 360

  19. Mean Length of Bleeding / Spotting Episodes in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

    Measured: From Day 1 to Day 90

  20. Mean Length of Bleeding / Spotting Episodes in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

    Measured: From Day 91 to Day 180

  21. Mean Length of Bleeding / Spotting Episodes in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

    Measured: From Day 181 to Day 270

  22. Mean Length of Bleeding / Spotting Episodes in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

    Measured: From Day 271 to Day 360

  23. Maximum Length of Bleeding / Spotting Episodes in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

    Measured: From Day 1 to Day 90

  24. Maximum Length of Bleeding / Spotting Episodes in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

    Measured: From Day 91 to Day 180

  25. Maximum Length of Bleeding / Spotting Episodes in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

    Measured: From Day 181 to Day 270

  26. Maximum Length of Bleeding / Spotting Episodes in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

    Measured: From Day 271 to Day 360

  27. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

    Measured: From Day 1 to Day 90

  28. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

    Measured: From Day 91 to Day 180

  29. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

    Measured: From Day 181 to Day 270

  30. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

    Measured: From Day 271 to Day 360

  31. Number of Days With Spotting-only in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment.

    Measured: From Day 1 to Day 90

  32. Number of Days With Spotting-only in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

    Measured: From Day 91 to Day 180

  33. Number of Days With Spotting-only in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

    Measured: From Day 181 to Day 270

  34. Number of Days With Spotting-only in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

    Measured: From Day 271 to Day 360

  35. Number of Spotting-only Episodes in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment.

    Measured: From Day 1 to Day 90

  36. Number of Spotting-only Episodes in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

    Measured: From Day 91 to Day 180

  37. Number of Spotting-only Episodes in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

    Measured: From Day 181 to Day 270

  38. Number of Spotting-only Episodes in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

    Measured: From Day 271 to Day 360

  39. Mean Length of Spotting-only Episodes in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment.

    Measured: From Day 1 to Day 90

  40. Mean Length of Spotting-only Episodes in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

    Measured: From Day 91 to Day 180

  41. Mean Length of Spotting-only Episodes in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

    Measured: From Day 181 to Day 270

  42. Mean Length of Spotting-only Episodes in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

    Measured: From Day 271 to Day 360

  43. Maximum Length of Spotting-only Episodes in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment.

    Measured: From Day 1 to Day 90

  44. Maximum Length of Spotting-only Episodes in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

    Measured: From Day 91 to Day 180

  45. Maximum Length of Spotting-only Episodes in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

    Measured: From Day 181 to Day 270

  46. Maximum Length of Spotting-only Episodes in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

    Measured: From Day 271 to Day 360

  47. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

    Measured: From Day 1 to Day 90

  48. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

    Measured: From Day 91 to Day 180

  49. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3

    Reference Period 3 is defined as Day 181 to Day 270 during study treatment.

    Measured: From Day 181 to Day 270

  50. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4

    Reference Period 4 is defined as Day 271 to Day 360 during study treatment.

    Measured: From Day 271 to Day 360

  51. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

    Measured: At Cycle 1 (28 days per Cycle)

  52. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

    Measured: At Cycle 3 (28 days per Cycle)

  53. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

    Measured: At Cycle 6 (28 days per Cycle)

  54. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

    Measured: At Cycle 13 (28 days per Cycle)

  55. Length of Withdrawal Bleeding Episodes at Cycle 1

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

    Measured: At Cycle 1 (28 days per Cycle)

  56. Length of Withdrawal Bleeding Episodes at Cycle 3

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

    Measured: At Cycle 3 (28 days per Cycle)

  57. Length of Withdrawal Bleeding Episodes at Cycle 6

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

    Measured: At Cycle 6 (28 days per Cycle)

  58. Length of Withdrawal Bleeding Episodes at Cycle 13

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.

    Measured: At Cycle 13 (28 days per Cycle)

  59. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

    Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

    Measured: At Cycle 1 (28 days per Cycle)

  60. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

    Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

    Measured: At Cycle 3 (28 days per Cycle)

  61. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

    Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

    Measured: At Cycle 6 (28 days per Cycle)

  62. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13

    Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

    Measured: At Cycle 13 (28 days per Cycle)

  63. Onset of Withdrawal Bleeding Episodes at Cycle 1

    Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).

    Measured: At Cycle 1 (28 days per Cycle)

  64. Onset of Withdrawal Bleeding Episodes at Cycle 3

    Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).

    Measured: At Cycle 3 (28 days per Cycle)

  65. Onset of Withdrawal Bleeding Episodes at Cycle 6

    Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).

    Measured: At Cycle 6 (28 days per Cycle)

  66. Onset of Withdrawal Bleeding Episodes at Cycle 13

    Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).

    Measured: At Cycle 13 (28 days per Cycle)

  67. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 1 (28 days per Cycle)

  68. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 3 (28 days per Cycle)

  69. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 6 (28 days per Cycle)

  70. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 13 (28 days per Cycle)

  71. Number of Intracyclic Bleeding Episodes at Cycle 1

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)

    Measured: At Cycle 1 (28 days per Cycle)

  72. Number of Intracyclic Bleeding Episodes at Cycle 3

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)

    Measured: At Cycle 3 (28 days per Cycle)

  73. Number of Intracyclic Bleeding Episodes at Cycle 6

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)

    Measured: At Cycle 6 (28 days per Cycle)

  74. Number of Intracyclic Bleeding Episodes at Cycle 13

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)

    Measured: At Cycle 13 (28 days per Cycle)

  75. Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 1 (28 days per Cycle)

  76. Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 3 (28 days per Cycle)

  77. Maximum Length of Intracyclic Bleeding Episodes at Cycle 6

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 6 (28 days per Cycle)

  78. Maximum Length of Intracyclic Bleeding Episodes at Cycle 13

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 13 (28 days per Cycle)

  79. Number of Intracyclic Bleeding Days at Cycle 1

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 1 (28 days per Cycle)

  80. Number of Intracyclic Bleeding Days at Cycle 3

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 3 (28 days per Cycle)

  81. Number of Intracyclic Bleeding Days at Cycle 6

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 6 (28 days per Cycle)

  82. Number of Intracyclic Bleeding Days at Cycle 13

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: At Cycle 13 (28 days per Cycle)

  83. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

    Measured: At Cycle 1 (28 days per Cycle)

  84. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

    Measured: At Cycle 3 (28 days per Cycle)

  85. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

    Measured: At Cycle 6 (28 days per Cycle)

  86. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.

    Measured: At Cycle 13 (28 days per Cycle)

  87. Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: Cycles 2 to 6 (28 days per Cycle)

  88. Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

    Measured: Cycles 2 to 13 (28 days per Cycle)

  89. Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)

    Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  90. Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)

    Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  91. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  92. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  93. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  94. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  95. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  96. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  97. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  98. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  99. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  100. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  101. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  102. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  103. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  104. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  105. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  106. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  107. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  108. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  109. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 6 (28 days per Cycle)

  110. Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment

    Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

    Measured: Baseline up to Cycle 13 (28 days per Cycle)

  111. Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6

    CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

    Measured: At Cycle 6 (28 days per Cycle)

  112. Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13

    CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

    Measured: At Cycle 13 (28 days per Cycle)

  113. Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6

    In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

    Measured: At Cycle 6 (28 days per Cycle)

  114. Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13

    In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

    Measured: At Cycle 13 (28 days per Cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2008 (estimated)
  2. Study start8 Sep 2008
  3. Primary completion10 May 2011
  4. Study completion10 May 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00754065
Sponsor's protocol ID
13108
Status last verified
Oct 2024
First submitted
16 Sep 2008
Last updated
20 Nov 2024
Data monitoring committee
No

Publications

  • 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.

    PubMed 23638631

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) and Ortho Tri Cyclen Lo in people with Contraception, run by Bayer at 59 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00754065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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