Trial Outcomes & Findings for Effect on Primary Dysmenorrhea (NCT NCT00909857)
NCT ID: NCT00909857
Last Updated: 2015-08-24
Results Overview
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).
COMPLETED
PHASE3
507 participants
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
2015-08-24
Participant Flow
Participants aged 14 to 50 years with a need for oral contraception suffering from primary dysmenorrhea were recruited at specialized study sites.
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).
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
253
|
254
|
|
Overall Study
Treated
|
234
|
230
|
|
Overall Study
COMPLETED
|
217
|
209
|
|
Overall Study
NOT COMPLETED
|
36
|
45
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
10
|
|
Overall Study
Adverse Event
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Did not receive study medication
|
19
|
24
|
Baseline Characteristics
Effect on Primary Dysmenorrhea
Baseline characteristics by cohort
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=230 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
Total
n=464 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.0 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
27.6 Years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
27.8 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Age, Customized
less than 18 years of age
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Customized
18 years of age or older
|
223 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
440 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
234 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
464 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=225 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=219 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
|
-4.6 Days
Standard Deviation 4.6
|
-4.2 Days
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=225 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=219 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
-10.0 Scores on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=225 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=219 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
-3.7 Days
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=225 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=219 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
0.1 Days
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=225 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=219 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
-6.6 Tablets
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=225 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=219 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)
|
-4.5 Tablets
Standard Deviation 19.9
|
-5.6 Tablets
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=230 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
89.6 Percentage of participants
|
|
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
|
56.5 Percentage of participants
|
|
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
|
91.3 Percentage of participants
|
|
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
|
56.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=230 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
92.2 Percentage of Participants
|
|
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
|
90.0 Percentage of Participants
|
|
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
|
60.0 Percentage of Participants
|
|
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
|
61.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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
Participants were asked to express the degree of their satisfaction with study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=225 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=216 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants Satisfied With Study Treatment
Missing
|
0.9 Percentage of participants
|
1.3 Percentage of participants
|
|
Percentage of Participants Satisfied With Study Treatment
Very satisfied
|
53.4 Percentage of participants
|
50.4 Percentage of participants
|
|
Percentage of Participants Satisfied With Study Treatment
Saatisfied
|
32.1 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants Satisfied With Study Treatment
Neither satisfied nor dissatisfied
|
7.3 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants Satisfied With Study Treatment
Dissatisfied
|
2.1 Percentage of participants
|
3.5 Percentage of participants
|
|
Percentage of Participants Satisfied With Study Treatment
Very dissatisfied
|
0.4 Percentage of participants
|
0.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=201 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=197 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Number of Days With Bleeding or Spotting
|
20.0 Days
Standard Deviation 8.8
|
23.6 Days
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=201 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=197 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Number of Episodes With Bleeding or Spotting
|
3.9 Episodes
Standard Deviation 1.0
|
4.1 Episodes
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=201 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=197 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Mean Length of Bleeding or Spotting Episodes
|
5.17 Days
Standard Deviation 2.26
|
5.83 Days
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=201 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=197 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Maximum Length of Bleeding or Spotting Episodes
|
7.1 Days
Standard Deviation 3.8
|
8.4 Days
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=201 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=197 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode
|
3.6 Days
Standard Deviation 3.6
|
4.6 Days
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=201 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=197 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Number of Days With Spotting-only
|
7.3 Days
Standard Deviation 6.9
|
7.6 Days
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=201 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=197 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Number of Episodes With Spotting-only
|
0.5 Episodes
Standard Deviation 0.8
|
0.4 Episodes
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=67 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=51 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Mean Length of Spotting Only Episodes
|
3.29 Days
Standard Deviation 2.39
|
3.26 Days
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=67 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=51 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Maximum Length of Spotting Only Episodes
|
3.9 Days
Standard Deviation 3.1
|
3.6 Days
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: From day 1 to day 90Population: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=67 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=51 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Spotting Only Episode
|
1.2 Days
Standard Deviation 2.5
|
0.7 Days
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=222 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants With Withdrawal Bleeding at Cycle 1
|
91.2 Percentage of Participants
|
93.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=204 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=198 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants With Withdrawal Bleeding at Cycle 3
|
68.1 Percentage of Participants
|
79.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=206 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=207 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Length of Withdrawal Bleeding Episodes at Cycle 1
|
5.2 Days
Standard Deviation 2.7
|
5.4 Days
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=139 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=157 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Length of Withdrawal Bleeding Episodes at Cycle 3
|
4.5 Days
Standard Deviation 1.7
|
5.2 Days
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=206 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=207 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
|
3.7 Scores on a scale
Standard Deviation 1.0
|
4.0 Scores on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=139 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=157 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
|
3.7 Scores on a scale
Standard Deviation 0.8
|
4.1 Scores on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=206 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=207 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Onset of Withdrawal Bleeding Episodes at Cycle 1
|
4.8 Days
Standard Deviation 7.0
|
4.9 Days
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=139 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=157 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Onset of Withdrawal Bleeding Episodes at Cycle 3
|
3.1 Days
Standard Deviation 3.7
|
4.3 Days
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=222 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants With Intracyclic Bleeding at Cycle 1
|
19.0 Percentage of Participants
|
16.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=204 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=198 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants With Intracyclic Bleeding at Cycle 3
|
10.8 Percentage of Participants
|
11.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=222 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Number of Intracyclic Bleeding Episodes at Cycle 1
|
0.2 Episodes
Standard Deviation 0.5
|
0.2 Episodes
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=204 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=198 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Number of Intracyclic Bleeding Episodes at Cycle 3
|
0.1 Episodes
Standard Deviation 0.3
|
0.1 Episodes
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=43 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=37 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
|
6.0 Days
Standard Deviation 5.4
|
6.2 Days
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=22 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=23 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
|
5.5 Days
Standard Deviation 4.7
|
4.9 Days
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=222 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Number of Intracyclic Bleeding Days at Cycle 1
|
1.2 Days
Standard Deviation 3.5
|
1.0 Days
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=204 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=198 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Number of Intracyclic Bleeding Days at Cycle 3
|
0.6 Days
Standard Deviation 2.3
|
0.6 Days
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=43 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=37 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Spotting
|
53.5 Percentage of participants
|
62.2 Percentage of participants
|
|
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Light
|
30.2 Percentage of participants
|
10.8 Percentage of participants
|
|
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Normal
|
9.3 Percentage of participants
|
13.5 Percentage of participants
|
|
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Heavy
|
7.0 Percentage of participants
|
13.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=22 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=23 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Spotting
|
45.5 Percentage of participants
|
30.4 Percentage of participants
|
|
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Light
|
27.3 Percentage of participants
|
21.7 Percentage of participants
|
|
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Normal
|
13.6 Percentage of participants
|
30.4 Percentage of participants
|
|
Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Heavy
|
13.6 Percentage of participants
|
17.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=230 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
Missing
|
0.4 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
Never
|
38.0 Percentage of Participants
|
40.4 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
4 working hours
|
16.2 Percentage of Participants
|
16.1 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
1 working day
|
26.5 Percentage of Participants
|
29.6 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
>= 2 working days
|
18.8 Percentage of Participants
|
13.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=229 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
Missing
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
Never
|
47.9 Percentage of Participants
|
51.7 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
4 working hours
|
13.2 Percentage of Participants
|
11.7 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
1 working day
|
20.9 Percentage of Participants
|
23.9 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
>= 2 working days
|
17.9 Percentage of Participants
|
12.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=224 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=212 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
Missing
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
Never
|
78.6 Percentage of Participants
|
72.6 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
4 working hours
|
8.5 Percentage of Participants
|
6.5 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
1 working day
|
6.4 Percentage of Participants
|
8.7 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
>= 2 working days
|
2.1 Percentage of Participants
|
4.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=217 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
Missing
|
0.4 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
Never
|
85.9 Percentage of Participants
|
85.2 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
4 working hours
|
5.6 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
1 working day
|
3.0 Percentage of Participants
|
4.8 Percentage of Participants
|
|
Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
>= 2 working days
|
1.7 Percentage of Participants
|
1.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=173 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=174 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
|
0.00 Dollars
Interval 0.0 to 0.0
|
0.00 Dollars
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=206 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=195 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
|
5.46 Dollars
Interval 0.0 to 30.0
|
5.04 Dollars
Interval 0.0 to 27.49
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=173 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=176 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
|
0.00 Dollars
Interval 0.0 to 65.45
|
0.00 Dollars
Interval 0.0 to 65.45
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=172 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=172 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
|
0.00 Dollars
Interval 0.0 to 60.0
|
0.00 Dollars
Interval 0.0 to 295.98
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=174 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=174 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
|
0.00 Dollars
Interval 0.0 to 150.0
|
0.00 Dollars
Interval 0.0 to 74.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=170 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=170 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
|
0.00 Dollars
Interval 0.0 to 271.68
|
0.00 Dollars
Interval 0.0 to 98.17
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=177 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=175 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
|
0.00 Dollars
Interval 0.0 to 196.34
|
0.00 Dollars
Interval 0.0 to 110.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=183 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=179 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
|
0.00 Dollars
Interval 0.0 to 30.0
|
0.00 Dollars
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=192 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=194 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
|
0.00 Dollars
Interval 0.0 to 15.0
|
0.00 Dollars
Interval 0.0 to 42.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=223 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=210 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
Missing
|
0 Participants
|
0 Participants
|
|
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
Not assessed
|
1 Participants
|
1 Participants
|
|
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
Very much improved
|
63 Participants
|
42 Participants
|
|
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
Much improved
|
87 Participants
|
84 Participants
|
|
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
Minimally improved
|
49 Participants
|
54 Participants
|
|
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
No change
|
17 Participants
|
23 Participants
|
|
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
Minimally worse
|
6 Participants
|
3 Participants
|
|
Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
Much worse
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=223 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=210 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
Missing
|
1 Participants
|
0 Participants
|
|
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
Not assessed
|
1 Participants
|
1 Participants
|
|
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
Very much improved
|
60 Participants
|
46 Participants
|
|
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
Much improved
|
91 Participants
|
75 Participants
|
|
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
Minimally improved
|
47 Participants
|
57 Participants
|
|
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
No change
|
18 Participants
|
24 Participants
|
|
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
Minimally worse
|
5 Participants
|
4 Participants
|
|
Participants With Improvement in Participants' Assessment in the Clinical Global Impression
Much worse
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=229 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
89.6 Scores on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=217 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
92.5 Scores on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=229 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
77.35 Scores on a scale
Standard Deviation 20.56
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=217 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
84.79 Scores on a scale
Standard Deviation 17.36
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=229 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
72.6 Scores on a scale
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=217 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
76.4 Scores on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=229 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
|
62.6 Scores on a scale
Standard Deviation 18.0
|
62.2 Scores on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=217 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
|
68.2 Scores on a scale
Standard Deviation 17.0
|
67.2 Scores on a scale
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=229 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
72.7 Scores on a scale
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=217 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
76.5 Scores on a scale
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=229 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
79.4 Scores on a scale
Standard Deviation 32.7
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=217 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
|
89.6 Scores on a scale
Standard Deviation 23.0
|
87.9 Scores on a scale
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=229 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
|
81.91 Scores on a scale
Standard Deviation 31.50
|
79.18 Scores on a scale
Standard Deviation 34.74
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=217 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
83.87 Scores on a scale
Standard Deviation 30.28
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=229 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
51.8 Scores on a scale
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=226 Participants
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=217 Participants
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
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
|
74.0 Scores on a scale
Standard Deviation 22.1
|
Adverse Events
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Ethinyl Estradiol, Levonorgestrel (Miranova)
Serious adverse events
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 participants at risk
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=230 participants at risk
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/234
|
0.43%
1/230 • Number of events 1
|
|
Infections and infestations
Helminthic infection
|
0.43%
1/234 • Number of events 1
|
0.00%
0/230
|
|
Psychiatric disorders
Depression
|
0.00%
0/234
|
0.43%
1/230 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.43%
1/234 • Number of events 1
|
0.00%
0/230
|
Other adverse events
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=234 participants at risk
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
|
Ethinyl Estradiol, Levonorgestrel (Miranova)
n=230 participants at risk
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
|
|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
2.1%
5/234 • Number of events 10
|
0.87%
2/230 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
0.85%
2/234 • Number of events 2
|
2.2%
5/230 • Number of events 6
|
|
General disorders
Inflammation
|
3.0%
7/234 • Number of events 7
|
1.3%
3/230 • Number of events 3
|
|
Infections and infestations
Influenza
|
0.85%
2/234 • Number of events 2
|
2.2%
5/230 • Number of events 5
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
4/234 • Number of events 6
|
3.0%
7/230 • Number of events 10
|
|
Nervous system disorders
Headache
|
13.7%
32/234 • Number of events 55
|
14.8%
34/230 • Number of events 55
|
|
Nervous system disorders
Tension headache
|
6.0%
14/234 • Number of events 40
|
3.9%
9/230 • Number of events 43
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
3.0%
7/234 • Number of events 7
|
3.9%
9/230 • Number of events 9
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
1.3%
3/234 • Number of events 4
|
2.2%
5/230 • Number of events 6
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
37.2%
87/234 • Number of events 208
|
35.7%
82/230 • Number of events 210
|
|
Reproductive system and breast disorders
Metrorrhagia
|
7.7%
18/234 • Number of events 28
|
5.7%
13/230 • Number of events 17
|
|
Reproductive system and breast disorders
Cervix inflammation
|
3.8%
9/234 • Number of events 9
|
1.7%
4/230 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60