| 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. | 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. | Posted | | Mean | 95% Confidence Interval | Pregnancies per 100 years of exposure | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2 | Pooled FAS of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) (see first arm) and Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300). Regimen no. 2: 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.65(0.96 to 2.65)
- OG0011.92(1.22 to 2.89)
|
|
| |
| Secondary | Number of Bleeding Days (Including Spotting Days) | Number of days per participant with bleeding or spotting | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data. | Posted | | Mean | Standard Deviation | Days | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Number of Bleeding Days (Excluding Spotting Days) | Number of days per participant with bleeding (excluding spotting days) | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data. | Posted | | Mean | Standard Deviation | Days | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 1. | Posted | | Mean | Standard Deviation | Days | | Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 2. | Posted | | Mean | Standard Deviation | Days | | Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 3. | Posted | | Mean | Standard Deviation | Days | | Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 4. | Posted | | Mean | Standard Deviation | Days | | Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 1. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 2. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 3. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 4. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 5. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 6. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 7. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 8. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 9. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 10. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 11. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 12. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
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| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 13. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 14. | Posted | | Number | | Percentage of Participants | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Intracyclic Bleeding Days | Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings. | 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. | Posted | | Mean | Standard Deviation | Days | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Days | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) |
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| 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. | Full Analysis Set (ie, all treated participants). Only cycle data from participants with sufficient data to calculate cycle length are included. | Posted | | Mean | Standard Deviation | Days | | Up to 1 year | Cycles | Participants | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) | |
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