Contraception, Contraceptives, Oral, Ovulation Inhibition
Conditions
Keywords
Oral Contraception, Birth Control pill, Healthy women requesting oral contraception, Contraceptive efficacy
Brief summary
The purpose of this study is to determine whether the study drug is safe and effective.
Detailed description
The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.
Interventions
Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
\- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.
Exclusion criteria
\- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pearl Index | Up to 1 year | The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Bleeding Days (Excluding Spotting Days) | Up to 1 year | Number of days per participant with bleeding (excluding spotting days) |
| Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. | Day 1 to Day 90 | Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 1. Reference period 1 (Day 1 to Day 90) was a 90 day period starting with the initial intake of study medication (protocol-specified to occur on first day of menstrual or withdrawal bleeding after screening). Therefore, the first 90-day reference period contains additional bleeding days (associated with the menstrual cycle prior to the start of study medication) when compared to any other reference period. |
| Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. | Day 91 to Day 180 | Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 2. Reference period 2 (Day 91 to Day 180) was a 90-day period that started with the intake of study medication at the beginning of Cycle 4. |
| Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 | Day 181 to Day 270 | Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 3. Reference period 3 (Day 181 to Day 270) was a 90-day period that started with the intake of study medication at the beginning of Cycle 7. |
| Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 | Day 271 to Day 360 | Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 4. Reference period 4 (Day 271 to Day 360) was a 90-day period that started with the intake of study medication at the beginning of Cycle 10. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Number of Bleeding Days (Including Spotting Days) | Up to 1 year | Number of days per participant with bleeding or spotting |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who provided bleeding data for cycle 13 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300), although one women did receive 13 cycles of treatment. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who received treatment in cycle 14 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300). There were no participants who provided bleeding data for cycle 14 in the Flexible (extended) regimen no.2 of EE20/DRSP (BAY86-5300), although one woman did receive 14 cycles of treatment. |
| Number of Intracyclic Bleeding Days | Up to 1 year | Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings. |
| Number of Scheduled and Unscheduled Bleeding Days | Up to 1 year | Scheduled bleeding is any bleeding/spotting (bl/sp) that occurs during the tablet free interval through the next 4 days of the subsequent treatment cycle. Unscheduled bleeding is any bl/sp that occurs while taking active hormones, except for bl/sp that occurs during the tablet free interval through day 4 of the subsequent treatment cycle or bl/sp on days 1-7 of treatment cycle 1. |
| Length of Cycles | Up to 1 year | Cycle length per cycle. For the flexible and stop and go extended treatment arms, a treatment cycle started with the first day of pill intake after a tablet-free interval and ended with the last day of the subsequent tablet-free interval. A tablet-free interval (treatment withdrawal) was defined as at least 3 consecutive days without tablet intake. For the standard 24+4 treatment arm, a new cycle started each time a new blister pack of medication was started. |
| Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7 | Up to 1 year | A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. |
Countries
United States
Participant flow
Recruitment details
The date of first subject, first visit was 22 Oct 2007. The date of last subject, last visit was 11 Nov 2009.
Pre-assignment details
A total of 2450 subjects were screened ; 563 failed screening. The remaining 1887 subjects were assigned to treatment. Of these, 1864 (98.8%) were in the Full Analysis Set (FAS), ie, study medication was dispensed to them and they had at least 1 post-baseline observation. A total of 1196 (63.4%) subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment | 1,406 |
| Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | 232 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. | 226 |
| Total | 1,864 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 92 | 13 | 9 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 202 | 23 | 21 |
| Overall Study | Missing | 1 | 0 | 0 |
| Overall Study | Pregnancy | 20 | 4 | 6 |
| Overall Study | Primary Reason coded as 'Other' | 37 | 8 | 16 |
| Overall Study | Protocol Violation | 23 | 4 | 2 |
| Overall Study | Withdrawal by Subject | 171 | 21 | 17 |
Baseline characteristics
| Characteristic | Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Total |
|---|---|---|---|---|
| Age, Continuous | 25.2 years STANDARD_DEVIATION 4.5 | 26.8 years STANDARD_DEVIATION 6.8 | 27.3 years STANDARD_DEVIATION 6.4 | 25.7 years STANDARD_DEVIATION 5.2 |
| Sex: Female, Male Female | 1406 Participants | 232 Participants | 226 Participants | 1864 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 330 / 1,406 | 68 / 232 | 65 / 226 |
| serious Total, serious adverse events | 12 / 1,406 | 6 / 232 | 2 / 226 |
Outcome results
Primary
Pearl Index
The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.
Time frame: Up to 1 year
Population: Full Analysis Set of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) treatment arm. Pooled Full Analysis Sets of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) and Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Pearl Index | 1.65 Pregnancies per 100 years of exposure |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Pearl Index | 1.92 Pregnancies per 100 years of exposure |
Secondary
Length of Cycles
Cycle length per cycle. For the flexible and stop and go extended treatment arms, a treatment cycle started with the first day of pill intake after a tablet-free interval and ended with the last day of the subsequent tablet-free interval. A tablet-free interval (treatment withdrawal) was defined as at least 3 consecutive days without tablet intake. For the standard 24+4 treatment arm, a new cycle started each time a new blister pack of medication was started.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). Only cycle data from participants with sufficient data to calculate cycle length are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Length of Cycles | 70.9 Days | Standard Deviation 41.3 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Length of Cycles | 67.6 Days | Standard Deviation 39.1 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Length of Cycles | 28.8 Days | Standard Deviation 10.8 |
Secondary
Number of Bleeding Days (Excluding Spotting Days)
Number of days per participant with bleeding (excluding spotting days)
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Bleeding Days (Excluding Spotting Days) | 19.4 Days | Standard Deviation 15.7 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Bleeding Days (Excluding Spotting Days) | 21.4 Days | Standard Deviation 15.6 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Bleeding Days (Excluding Spotting Days) | 32.9 Days | Standard Deviation 23.5 |
Secondary
Number of Bleeding Days (Including Spotting Days)
Number of days per participant with bleeding or spotting
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Bleeding Days (Including Spotting Days) | 39.9 Days | Standard Deviation 29.6 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Bleeding Days (Including Spotting Days) | 46.8 Days | Standard Deviation 33.1 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Bleeding Days (Including Spotting Days) | 51.8 Days | Standard Deviation 34.6 |
p-value: 0.000195% CI: [-16.3, -7.394]t-test, 2 sided
Secondary
Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.
Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 1. Reference period 1 (Day 1 to Day 90) was a 90 day period starting with the initial intake of study medication (protocol-specified to occur on first day of menstrual or withdrawal bleeding after screening). Therefore, the first 90-day reference period contains additional bleeding days (associated with the menstrual cycle prior to the start of study medication) when compared to any other reference period.
Time frame: Day 1 to Day 90
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. | Including days with spotting | 16.6 Days | Standard Deviation 12.2 |
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. | Excluding days with spotting | 8.3 Days | Standard Deviation 6.9 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. | Including days with spotting | 18.5 Days | Standard Deviation 12.9 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. | Excluding days with spotting | 9.1 Days | Standard Deviation 7.2 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. | Including days with spotting | 19.7 Days | Standard Deviation 9.8 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. | Excluding days with spotting | 12.6 Days | Standard Deviation 6.5 |
Secondary
Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.
Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 2. Reference period 2 (Day 91 to Day 180) was a 90-day period that started with the intake of study medication at the beginning of Cycle 4.
Time frame: Day 91 to Day 180
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. | Including days with spotting | 11.0 Days | Standard Deviation 9.7 |
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. | Excluding days with spotting | 5.1 Days | Standard Deviation 5.2 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. | Excluding days with spotting | 5.4 Days | Standard Deviation 5.5 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. | Including days with spotting | 12.5 Days | Standard Deviation 10.5 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. | Including days with spotting | 14.8 Days | Standard Deviation 8 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. | Excluding days with spotting | 9.7 Days | Standard Deviation 6.3 |
Secondary
Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3
Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 3. Reference period 3 (Day 181 to Day 270) was a 90-day period that started with the intake of study medication at the beginning of Cycle 7.
Time frame: Day 181 to Day 270
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 | Including days with spotting | 10.0 Days | Standard Deviation 8.7 |
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 | Excluding days with spotting | 4.7 Days | Standard Deviation 4.8 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 | Including days with spotting | 11.4 Days | Standard Deviation 10.8 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 | Excluding days with spotting | 4.9 Days | Standard Deviation 5 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 | Including days with spotting | 14.8 Days | Standard Deviation 8 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 | Excluding days with spotting | 9.4 Days | Standard Deviation 6.5 |
Secondary
Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4
Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 4. Reference period 4 (Day 271 to Day 360) was a 90-day period that started with the intake of study medication at the beginning of Cycle 10.
Time frame: Day 271 to Day 360
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 | Including days with spotting | 9.0 Days | Standard Deviation 9.2 |
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 | Excluding days with spotting | 4.2 Days | Standard Deviation 4.8 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 | Including days with spotting | 9.5 Days | Standard Deviation 10.3 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 | Excluding days with spotting | 4.0 Days | Standard Deviation 4.8 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 | Including days with spotting | 13.6 Days | Standard Deviation 7.3 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 | Excluding days with spotting | 8.4 Days | Standard Deviation 5.5 |
Secondary
Number of Intracyclic Bleeding Days
Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate intracyclic bleeding.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Intracyclic Bleeding Days | Including spotting only episodes | 8.0 Days | Standard Deviation 11.8 |
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Intracyclic Bleeding Days | Excluding spotting only episodes | 3.6 Days | Standard Deviation 7.9 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Intracyclic Bleeding Days | Including spotting only episodes | 14.4 Days | Standard Deviation 19.1 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Intracyclic Bleeding Days | Excluding spotting only episodes | 7.3 Days | Standard Deviation 12.8 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Intracyclic Bleeding Days | Including spotting only episodes | 7.1 Days | Standard Deviation 12.7 |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Number of Intracyclic Bleeding Days | Excluding spotting only episodes | 5.2 Days | Standard Deviation 11.4 |
Secondary
Number of Scheduled and Unscheduled Bleeding Days
Scheduled bleeding is any bleeding/spotting (bl/sp) that occurs during the tablet free interval through the next 4 days of the subsequent treatment cycle. Unscheduled bleeding is any bl/sp that occurs while taking active hormones, except for bl/sp that occurs during the tablet free interval through day 4 of the subsequent treatment cycle or bl/sp on days 1-7 of treatment cycle 1.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate scheduled/unscheduled bleeding. Analysis was only performed for the flexible and stop-and-go extended regimens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Scheduled and Unscheduled Bleeding Days | Scheduled bleeding days | 20.6 Days | Standard Deviation 14.1 |
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Number of Scheduled and Unscheduled Bleeding Days | Unscheduled bleeding days | 20.0 Days | Standard Deviation 20.4 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Scheduled and Unscheduled Bleeding Days | Scheduled bleeding days | 21.9 Days | Standard Deviation 13.9 |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Number of Scheduled and Unscheduled Bleeding Days | Unscheduled bleeding days | 25.3 Days | Standard Deviation 27.8 |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1 | 84.2 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1 | 83.8 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1 | 66.8 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 10.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10 | 78.9 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10 | 70.0 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10 | 84.6 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 11.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11 | 55.6 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11 | 62.5 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11 | 85.9 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12 | 0 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12 | 33.3 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12 | 78.6 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who provided bleeding data for cycle 13 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300), although one women did receive 13 cycles of treatment.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 13.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13 | 0 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13 | 20.5 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who received treatment in cycle 14 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300). There were no participants who provided bleeding data for cycle 14 in the Flexible (extended) regimen no.2 of EE20/DRSP (BAY86-5300), although one woman did receive 14 cycles of treatment.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14 | 9.1 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2 | 85.9 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2 | 84.7 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2 | 86.7 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3 | 78.6 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3 | 79.2 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3 | 84.6 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4 | 73.4 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4 | 66.1 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4 | 86.3 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 5.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5 | 78.0 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5 | 69.0 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5 | 85.8 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6 | 77.7 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6 | 69.8 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6 | 85.2 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 7.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7 | 78.3 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7 | 70.0 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7 | 84.0 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8 | 82.1 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8 | 69.2 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8 | 86.7 Percentage of Participants |
Secondary
Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9
A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time frame: Up to 1 year
Population: Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9 | 73.9 Percentage of Participants |
| Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9 | 80.0 Percentage of Participants |
| Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) | Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9 | 85.5 Percentage of Participants |