Primary Dysmenorrhea
Conditions
Keywords
Primary Dysmenorrhea, Oral Contraception
Brief summary
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
Interventions
Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
DRUGEthinyl estradiol, Levonorgestrel (Miranova)
Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval
DRUGPlacebo Match to SH T00658ID
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
DRUGPlacebo Match to SH D593B
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of \>/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score * Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent * Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit) * Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1. * Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.
Exclusion criteria
* Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment) * Obesity: body mass index (BMI) \> 32 kg/m2 * Hypersensitivity to any of the study drug ingredients * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results * Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding * Abuse of alcohol, drugs, or medicines (e.g. laxatives) * Other contraceptive methods: * Sterilization * Oral, vaginal or transdermal hormonal contraception during treatment * Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1 * Simultaneous participation in another clinical trial or 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period). |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Percentage of Participants Satisfied With Study Treatment | From cycle 1 to cycle 3 (28 days per cycle) | Participants were asked to express the degree of their satisfaction with study treatment. |
| Number of Days With Bleeding or Spotting | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Number of Episodes With Bleeding or Spotting | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Mean Length of Bleeding or Spotting Episodes | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Maximum Length of Bleeding or Spotting Episodes | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Number of Days With Spotting-only | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Number of Episodes With Spotting-only | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Mean Length of Spotting Only Episodes | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Maximum Length of Spotting Only Episodes | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Difference in Duration Between Longest and Shortest Spotting Only Episode | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
| Percentage of Participants With Withdrawal Bleeding at Cycle 1 | At cycle 1 (28 days per cycle) | Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Percentage of Participants With Withdrawal Bleeding at Cycle 3 | At cycle 3 (28 days per cycle) | Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Length of Withdrawal Bleeding Episodes at Cycle 1 | At cycle 1 (28 days per cycle) | Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Length of Withdrawal Bleeding Episodes at Cycle 3 | At cycle 3 (28 days per cycle) | Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 | At cycle 1 (28 days per cycle) | Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy. |
| Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 | At cycle 3 (28 days per cycle) | Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy. |
| Onset of Withdrawal Bleeding Episodes at Cycle 1 | At cycle 1 (28 days per cycle) | Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Onset of Withdrawal Bleeding Episodes at Cycle 3 | At cycle 3 (28 days per cycle) | Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Percentage of Participants With Intracyclic Bleeding at Cycle 1 | At cycle 1 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Percentage of Participants With Intracyclic Bleeding at Cycle 3 | At cycle 3 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Number of Intracyclic Bleeding Episodes at Cycle 1 | At cycle 1 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Number of Intracyclic Bleeding Episodes at Cycle 3 | At cycle 3 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 | At cycle 1 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 | At cycle 3 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. |
| Number of Intracyclic Bleeding Days at Cycle 1 | At cycle 1 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted. |
| Number of Intracyclic Bleeding Days at Cycle 3 | At cycle 3 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted. |
| Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | At cycle 1 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy. |
| Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | At cycle 3 (28 days per cycle) | Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy. |
| Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | At screening (28 days) | The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. |
| Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | At Baseline (28 days per cycle) | The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. |
| Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | At cycle 2 (28 days per cycle) | The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. |
| Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | At final examination (28 days) | The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. |
| Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | At screening (average over 3 months before screening) | The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. |
| Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | At screening (average over 3 months before screening) | The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. |
| Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | At screening (average over 3 months before screening) | The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. |
| Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | At screening (average over 3 months before screening) | The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. |
| Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | At screening (average over 3 months before screening) | The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. |
| Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | At screening (average over 3 months before screening) | The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. |
| Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | At screening (average over 3 months before screening) | The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. |
| Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | At screening (average over 3 months before screening) | The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. |
| Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | At screening (average over 3 months before screening) | The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. |
| Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | At cycle 2 (28 days per cycle) | The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Investigators were asked to rate the participants' improvement during the course of the study. |
| Participants With Improvement in Participants' Assessment in the Clinical Global Impression | At cycle 2 (28 days per cycle) | The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study. |
| Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | At baseline cycle (28 days per cycle) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | at final examination (28 days) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | At baseline cycle (28 days per cycle) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | At final examination (28 days) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | At baseline cycle (28 days per cycle) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | At final examination (28 days) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | At baseline cycle (28 days per cycle) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | At final examination (28 days) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. 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: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst) |
| General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | At final examination (28 days) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | At baseline cycle (28 days per cycle) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | At final examination (28 days) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | At baseline cycle (28 days per cycle) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | At final examination (28 days) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | At baseline cycle (28 days per cycle) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | At final examination (28 days) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
| General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | At baseline cycle (28 days per cycle) | The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) |
Countries
Canada, Chile, Germany, Italy, Philippines, United States
Participant flow
Recruitment details
Participants aged 14 to 50 years with a need for oral contraception suffering from primary dysmenorrhea were recruited at specialized study sites.
Pre-assignment details
Out of 771 participants screened, 264 failed screening, mostly due to not meeting in-/exclusion criteria (155), withdrawal of consent (49), loss to follow-up (36) or pregnancy (10). Thus, 507 participants were randomized (253 to Estradiol valerate/Dienogest and 254 to Ethinyl estradiol/Levonorgestrel).
Participants by arm
| Arm | Count |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles | 234 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles | 230 |
| Total | 464 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 5 |
| Overall Study | Did not receive study medication | 19 | 24 |
| Overall Study | Lost to Follow-up | 2 | 5 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 10 |
Baseline characteristics
| Characteristic | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Ethinyl Estradiol, Levonorgestrel (Miranova) | Total |
|---|---|---|---|
| Age, Continuous | 28.0 Years STANDARD_DEVIATION 7.9 | 27.6 Years STANDARD_DEVIATION 8 | 27.8 Years STANDARD_DEVIATION 7.9 |
| Age, Customized 18 years of age or older | 223 Participants | 217 Participants | 440 Participants |
| Age, Customized less than 18 years of age | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Female | 234 Participants | 230 Participants | 464 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 131 / 234 | 122 / 230 |
| serious Total, serious adverse events | 2 / 234 | 2 / 230 |
Outcome results
Primary
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain | -4.6 Days | Standard Deviation 4.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain | -4.2 Days | Standard Deviation 4.2 |
Secondary
Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At baseline cycle (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 50.7 Scores on a scale | Standard Deviation 24.4 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 51.8 Scores on a scale | Standard Deviation 23 |
Secondary
Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At final examination (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 77.0 Scores on a scale | Standard Deviation 21.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 74.0 Scores on a scale | Standard Deviation 22.1 |
Secondary
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding
Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding | 0.3 Days | Standard Deviation 2.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding | 0.1 Days | Standard Deviation 2 |
Secondary
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding
Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding | -4.0 Days | Standard Deviation 5.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding | -3.7 Days | Standard Deviation 5.7 |
Secondary
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used) | -4.5 Tablets | Standard Deviation 19.9 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used) | -5.6 Tablets | Standard Deviation 14.3 |
Secondary
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode) | -6.2 Tablets | Standard Deviation 14.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode) | -6.6 Tablets | Standard Deviation 12.3 |
Secondary
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain
Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. 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: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain | -10.6 Scores on a scale | Standard Deviation 9.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain | -10.0 Scores on a scale | Standard Deviation 8.9 |
Secondary
Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode | 3.6 Days | Standard Deviation 3.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode | 4.6 Days | Standard Deviation 5.6 |
Secondary
Difference in Duration Between Longest and Shortest Spotting Only Episode
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Difference in Duration Between Longest and Shortest Spotting Only Episode | 1.2 Days | Standard Deviation 2.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Difference in Duration Between Longest and Shortest Spotting Only Episode | 0.7 Days | Standard Deviation 1.5 |
Secondary
General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At baseline cycle (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 75.8 Scores on a scale | Standard Deviation 17.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 72.7 Scores on a scale | Standard Deviation 16.9 |
Secondary
General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At final examination (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 77.2 Scores on a scale | Standard Deviation 17.9 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 76.5 Scores on a scale | Standard Deviation 16.6 |
Secondary
Length of Withdrawal Bleeding Episodes at Cycle 1
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 1 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Length of Withdrawal Bleeding Episodes at Cycle 1 | 5.2 Days | Standard Deviation 2.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Length of Withdrawal Bleeding Episodes at Cycle 1 | 5.4 Days | Standard Deviation 2.4 |
Secondary
Length of Withdrawal Bleeding Episodes at Cycle 3
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Length of Withdrawal Bleeding Episodes at Cycle 3 | 4.5 Days | Standard Deviation 1.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Length of Withdrawal Bleeding Episodes at Cycle 3 | 5.2 Days | Standard Deviation 2 |
Secondary
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
Time frame: At cycle 1 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 | 3.7 Scores on a scale | Standard Deviation 1 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 | 4.0 Scores on a scale | Standard Deviation 0.9 |
Secondary
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
Time frame: At cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 | 3.7 Scores on a scale | Standard Deviation 0.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 | 4.1 Scores on a scale | Standard Deviation 0.8 |
Secondary
Maximum Length of Bleeding or Spotting Episodes
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Maximum Length of Bleeding or Spotting Episodes | 7.1 Days | Standard Deviation 3.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Maximum Length of Bleeding or Spotting Episodes | 8.4 Days | Standard Deviation 5.6 |
Secondary
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 1 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 | 6.0 Days | Standard Deviation 5.4 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 | 6.2 Days | Standard Deviation 5.7 |
Secondary
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 | 5.5 Days | Standard Deviation 4.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 | 4.9 Days | Standard Deviation 4.1 |
Secondary
Maximum Length of Spotting Only Episodes
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Maximum Length of Spotting Only Episodes | 3.9 Days | Standard Deviation 3.1 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Maximum Length of Spotting Only Episodes | 3.6 Days | Standard Deviation 3 |
Secondary
Mean Length of Bleeding or Spotting Episodes
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Mean Length of Bleeding or Spotting Episodes | 5.17 Days | Standard Deviation 2.26 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Mean Length of Bleeding or Spotting Episodes | 5.83 Days | Standard Deviation 2.35 |
Secondary
Mean Length of Spotting Only Episodes
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Mean Length of Spotting Only Episodes | 3.29 Days | Standard Deviation 2.39 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Mean Length of Spotting Only Episodes | 3.26 Days | Standard Deviation 2.79 |
Secondary
Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At baseline cycle (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants wit assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 73.6 Scores on a scale | Standard Deviation 15.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 72.6 Scores on a scale | Standard Deviation 16.3 |
Secondary
Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At final examination (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 77.3 Scores on a scale | Standard Deviation 14.9 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 76.4 Scores on a scale | Standard Deviation 14.7 |
Secondary
Number of Days With Bleeding or Spotting
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Number of Days With Bleeding or Spotting | 20.0 Days | Standard Deviation 8.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Number of Days With Bleeding or Spotting | 23.6 Days | Standard Deviation 9.7 |
Secondary
Number of Days With Spotting-only
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Number of Days With Spotting-only | 7.3 Days | Standard Deviation 6.9 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Number of Days With Spotting-only | 7.6 Days | Standard Deviation 7.5 |
Secondary
Number of Episodes With Bleeding or Spotting
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Number of Episodes With Bleeding or Spotting | 3.9 Episodes | Standard Deviation 1 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Number of Episodes With Bleeding or Spotting | 4.1 Episodes | Standard Deviation 0.8 |
Secondary
Number of Episodes With Spotting-only
Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
Time frame: From day 1 to day 90
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Number of Episodes With Spotting-only | 0.5 Episodes | Standard Deviation 0.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Number of Episodes With Spotting-only | 0.4 Episodes | Standard Deviation 0.7 |
Secondary
Number of Intracyclic Bleeding Days at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
Time frame: At cycle 1 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Number of Intracyclic Bleeding Days at Cycle 1 | 1.2 Days | Standard Deviation 3.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Number of Intracyclic Bleeding Days at Cycle 1 | 1.0 Days | Standard Deviation 3.3 |
Secondary
Number of Intracyclic Bleeding Days at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
Time frame: At cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Number of Intracyclic Bleeding Days at Cycle 3 | 0.6 Days | Standard Deviation 2.3 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Number of Intracyclic Bleeding Days at Cycle 3 | 0.6 Days | Standard Deviation 2.1 |
Secondary
Number of Intracyclic Bleeding Episodes at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 1 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Number of Intracyclic Bleeding Episodes at Cycle 1 | 0.2 Episodes | Standard Deviation 0.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Number of Intracyclic Bleeding Episodes at Cycle 1 | 0.2 Episodes | Standard Deviation 0.4 |
Secondary
Number of Intracyclic Bleeding Episodes at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Number of Intracyclic Bleeding Episodes at Cycle 3 | 0.1 Episodes | Standard Deviation 0.3 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Number of Intracyclic Bleeding Episodes at Cycle 3 | 0.1 Episodes | Standard Deviation 0.4 |
Secondary
Onset of Withdrawal Bleeding Episodes at Cycle 1
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 1 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Onset of Withdrawal Bleeding Episodes at Cycle 1 | 4.8 Days | Standard Deviation 7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Onset of Withdrawal Bleeding Episodes at Cycle 1 | 4.9 Days | Standard Deviation 5.9 |
Secondary
Onset of Withdrawal Bleeding Episodes at Cycle 3
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Onset of Withdrawal Bleeding Episodes at Cycle 3 | 3.1 Days | Standard Deviation 3.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Onset of Withdrawal Bleeding Episodes at Cycle 3 | 4.3 Days | Standard Deviation 4.4 |
Secondary
Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time frame: At screening (average over 3 months before screening)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
Secondary
Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time frame: At screening (average over 3 months before screening)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
Secondary
Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time frame: At screening (average over 3 months before screening)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
Secondary
Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time frame: At screening (average over 3 months before screening)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
Secondary
Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time frame: At screening (average over 3 months before screening)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
Secondary
Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time frame: At screening (average over 3 months before screening)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
Secondary
Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time frame: At screening (average over 3 months before screening)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 5.46 Dollars |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 5.04 Dollars |
Secondary
Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time frame: At screening (average over 3 months before screening)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
Secondary
Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
Time frame: At screening (average over 3 months before screening)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | 0.00 Dollars |
Secondary
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study.
Time frame: At cycle 2 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Missing | 1 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Not assessed | 1 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Very much improved | 60 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Much improved | 91 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Minimally improved | 47 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | No change | 18 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Minimally worse | 5 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Much worse | 0 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Much worse | 3 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Missing | 0 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Minimally improved | 57 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Not assessed | 1 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Minimally worse | 4 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Very much improved | 46 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | No change | 24 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in Participants' Assessment in the Clinical Global Impression | Much improved | 75 Participants |
Secondary
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Investigators were asked to rate the participants' improvement during the course of the study.
Time frame: At cycle 2 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Very much improved | 63 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Missing | 0 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Not assessed | 1 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Much improved | 87 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Minimally improved | 49 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | No change | 17 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Minimally worse | 6 Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Much worse | 0 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Much worse | 6 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Very much improved | 42 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Minimally improved | 54 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Missing | 0 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Minimally worse | 3 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Not assessed | 1 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | No change | 23 Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression | Much improved | 84 Participants |
Secondary
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Time frame: At Baseline (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | Missing | 0.0 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | 4 working hours | 13.2 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | Never | 47.9 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | >= 2 working days | 17.9 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | 1 working day | 20.9 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | >= 2 working days | 12.2 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | 1 working day | 23.9 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | Missing | 0.0 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | Never | 51.7 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | 4 working hours | 11.7 Percentage of Participants |
Secondary
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Time frame: At cycle 2 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | >= 2 working days | 2.1 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | Never | 78.6 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | 4 working hours | 8.5 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | 1 working day | 6.4 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | Missing | 0.0 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | 1 working day | 8.7 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | Missing | 0.0 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | 4 working hours | 6.5 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | Never | 72.6 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | >= 2 working days | 4.3 Percentage of Participants |
Secondary
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Time frame: At final examination (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | Missing | 0.4 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | Never | 85.9 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | 4 working hours | 5.6 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | 1 working day | 3.0 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | >= 2 working days | 1.7 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | >= 2 working days | 1.7 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | Missing | 0.0 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | 4 working hours | 2.6 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | Never | 85.2 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | 1 working day | 4.8 Percentage of Participants |
Secondary
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
Time frame: At screening (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | Missing | 0.4 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | 1 working day | 26.5 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | Never | 38.0 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | >= 2 working days | 18.8 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | 4 working hours | 16.2 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | >= 2 working days | 13.9 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | 4 working hours | 16.1 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | Missing | 0.0 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | Never | 40.4 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening | 1 working day | 29.6 Percentage of Participants |
Secondary
Percentage of Participants Satisfied With Study Treatment
Participants were asked to express the degree of their satisfaction with study treatment.
Time frame: From cycle 1 to cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Satisfied With Study Treatment | Saatisfied | 32.1 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Satisfied With Study Treatment | Neither satisfied nor dissatisfied | 7.3 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Satisfied With Study Treatment | Dissatisfied | 2.1 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Satisfied With Study Treatment | Very dissatisfied | 0.4 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Satisfied With Study Treatment | Missing | 0.9 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants Satisfied With Study Treatment | Very satisfied | 53.4 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Satisfied With Study Treatment | Very dissatisfied | 0.4 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Satisfied With Study Treatment | Saatisfied | 30.0 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Satisfied With Study Treatment | Very satisfied | 50.4 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Satisfied With Study Treatment | Neither satisfied nor dissatisfied | 8.3 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Satisfied With Study Treatment | Missing | 1.3 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants Satisfied With Study Treatment | Dissatisfied | 3.5 Percentage of participants |
Secondary
Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)
Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | Baseline period-daily activities impaired | 93.2 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | Baseline period- leisure activities impaired | 92.3 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | Treatment period-daily activities impaired | 54.7 Percentage of Participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | Treatment period- leisure activities impaired | 52.6 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | Treatment period- leisure activities impaired | 61.3 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | Baseline period-daily activities impaired | 92.2 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | Treatment period-daily activities impaired | 60.0 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | Baseline period- leisure activities impaired | 90.0 Percentage of Participants |
Secondary
Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)
Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Time frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | Baseline period-daily activities impaired | 92.3 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | Baseline period- leisure activities impaired | 90.6 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | Treatment period-daily activities impaired | 51.7 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | Treatment period- leisure activities impaired | 47.9 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | Treatment period- leisure activities impaired | 56.5 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | Baseline period-daily activities impaired | 91.3 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | Treatment period-daily activities impaired | 56.5 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | Baseline period- leisure activities impaired | 89.6 Percentage of participants |
Secondary
Percentage of Participants With Intracyclic Bleeding at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 1 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Intracyclic Bleeding at Cycle 1 | 19.0 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Intracyclic Bleeding at Cycle 1 | 16.7 Percentage of Participants |
Secondary
Percentage of Participants With Intracyclic Bleeding at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Intracyclic Bleeding at Cycle 3 | 10.8 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Intracyclic Bleeding at Cycle 3 | 11.6 Percentage of Participants |
Secondary
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
Time frame: At cycle 1 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | Spotting | 53.5 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | Light | 30.2 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | Normal | 9.3 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | Heavy | 7.0 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | Heavy | 13.5 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | Spotting | 62.2 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | Normal | 13.5 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | Light | 10.8 Percentage of participants |
Secondary
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
Time frame: At cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | Spotting | 45.5 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | Heavy | 13.6 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | Light | 27.3 Percentage of participants |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | Normal | 13.6 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | Heavy | 17.4 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | Normal | 30.4 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | Light | 21.7 Percentage of participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | Spotting | 30.4 Percentage of participants |
Secondary
Percentage of Participants With Withdrawal Bleeding at Cycle 1
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 1 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Withdrawal Bleeding at Cycle 1 | 91.2 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Withdrawal Bleeding at Cycle 1 | 93.2 Percentage of Participants |
Secondary
Percentage of Participants With Withdrawal Bleeding at Cycle 3
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
Time frame: At cycle 3 (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Percentage of Participants With Withdrawal Bleeding at Cycle 3 | 68.1 Percentage of Participants |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Percentage of Participants With Withdrawal Bleeding at Cycle 3 | 79.3 Percentage of Participants |
Secondary
Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At baseline cycle (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 90.2 Scores on a scale | Standard Deviation 16.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 89.6 Scores on a scale | Standard Deviation 17.5 |
Secondary
Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: at final examination (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 93.7 Scores on a scale | Standard Deviation 14.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 92.5 Scores on a scale | Standard Deviation 15 |
Secondary
Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At baseline cycle (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 81.91 Scores on a scale | Standard Deviation 31.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 79.18 Scores on a scale | Standard Deviation 34.74 |
Secondary
Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At final examination (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 88.64 Scores on a scale | Standard Deviation 26.36 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 83.87 Scores on a scale | Standard Deviation 30.28 |
Secondary
Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At baseline cycle (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 77.8 Scores on a scale | Standard Deviation 33.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 79.4 Scores on a scale | Standard Deviation 32.7 |
Secondary
Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At final examination (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 89.6 Scores on a scale | Standard Deviation 23 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 87.9 Scores on a scale | Standard Deviation 25.9 |
Secondary
Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At baseline cycle (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 78.85 Scores on a scale | Standard Deviation 18.99 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 77.35 Scores on a scale | Standard Deviation 20.56 |
Secondary
Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At final examination (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 85.95 Scores on a scale | Standard Deviation 19.09 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 84.79 Scores on a scale | Standard Deviation 17.36 |
Secondary
Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At baseline cycle (28 days per cycle)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 62.6 Scores on a scale | Standard Deviation 18 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | 62.2 Scores on a scale | Standard Deviation 18.2 |
Secondary
Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)
Time frame: At final examination (28 days)
Population: Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 68.2 Scores on a scale | Standard Deviation 17 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | 67.2 Scores on a scale | Standard Deviation 16.8 |