| Primary | Red Blood Cell (RBC) Folate Level at 24 Weeks | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Least Squares Mean | 95% Confidence Interval | nmol/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001406.91(1354.13 to 1459.68)
- OG0011022.21(934.6 to 1109.82)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the RBC folate levels at week 24 was 0. | ANCOVA | Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (RBC folate) as covariate | <0.0001 | | Mean Difference (Final Values) | 384.70 | | | | 95 | 282.42 | 486.98 | | | Difference = DRSP/EE/MTHF - YAZ | No | Superiority or Other | | |
|
| Primary | Plasma Folate Level at 24 Weeks | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Least Squares Mean | 95% Confidence Interval | nmol/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Neural Tube Defect (NTD) Risk Reduction at Week 24 | The mean NTD risk reduction evaluated as the change from Baseline to Week 24 in NTD risk based on the formula of Daly et al (J Amer Med Assoc 1995;274(21):1698-702); NTD risk=exp (1.6463-1.2193 x natural log [RBC folate]) where natural log [RBC folate] is the natural log of RBC folate measured in nmol/L; Change from Baseline to Week 24 in NTD risk=NTD risk at Week 24 - NTD risk at Baseline | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | per 1000 birth | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | nmol/L | | baseline and up to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | baseline and up to week 8 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | baseline and up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | baseline and up to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | baseline and up to week 20 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Folate Levels at Week 4 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | nmol/L | | baseline and up to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Folate Levels at Week 8 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | µg/L | | baseline and up to week 8 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Folate Levels at Week 12 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | baseline and up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Folate Levels at Week 16 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | baseline and up to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Folate Levels at Week 20 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | baseline and up to week 20 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Homocysteine Levels at Week 4 | Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | µg/L | | baseline and up to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Homocysteine Levels at Week 8 | Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | µg/L | | baseline and up to week 8 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Homocysteine Levels at Week 12 | Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | µg/L | | baseline and up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Homocysteine Levels at Week 16 | Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | µg/L | | baseline and up to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Homocysteine Levels at Week 20 | Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | µg/L | | baseline and up to week 20 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Secondary | Mean Change From Baseline in Plasma Homocysteine Levels at Week 24 | Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | µg/L | | baseline and up to week 24 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | nmol/L | | at baseline (week 0) | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | nmol/L | | at baseline (week 0) | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | nmol/L | | up to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 8 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 8 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
| |
| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 20 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 20 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 24 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24 | RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 24 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | nmol/L | | at baseline (week 0) | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | nmol/L | | at baseline (week 0) | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24 | Posted | | Mean | Standard Deviation | nmol/L | | up to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 8 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 8 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 20 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 20 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 24 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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| Post-Hoc | Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24 | Folate concentrations in plasma were determined by an appropriately validated microbiological assay. | Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24. | Posted | | Mean | Standard Deviation | nmol/L | | up to week 24 | | | | ID | Title | Description |
|---|
| OG000 | Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) | 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks | | OG001 | Drospirenone (DRSP)/Ethinylestradiol (EE) | 1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks |
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