| Primary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels | Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per-protocol (PP) population. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | pmol/L | | Baseline through Month 6 | | | | ID | Title | Description |
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| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00045.0± 15.24
- OG00156.8± 15.60
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| | 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 |
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| | ANCOVA | Least Squares mean difference: Treatment I - Treatment II | 0.5892 | The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect. | Least Squares Mean Difference | -11.8 | | | 2-Sided | 95 | -54.75 | 31.17 | | | | | Superiority or Other (legacy) | | |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer | Normal range for this hemostatic parameter was 0 to 729 mcg/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | mcg/L | | Baseline through Month 6 | | | | ID | Title | Description |
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| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen | The normal range for this hemostatic parameter was 50% to 147%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | percentage of normal 50% to 147% | | Baseline through Month 6 | | | | ID | Title | Description |
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| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity | The normal range for this hemostatic parameter was 70% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline through Month 6 | | | | ID | Title | Description |
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| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin | Normal range for this hemostatic parameter was 75% to 130%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline through Month 6 | | | | ID | Title | Description |
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| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity | Normal range for this hemostatic parameter was 70% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline through Month 6 | | | | ID | Title | Description |
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| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII | Normal range for this hemostatic parameter was 60% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline through Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII | Normal range for this hemostatic parameter was 50% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline through Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance | This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 2.00 to 3.36. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | ratio | | Baseline through Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance | This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 0.32 to 1.79. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | ratio | | Baseline through Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin | Normal range for this adrenal parameter was 1906.448 to 4520.504 mg/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | mg/L | | Baseline through Month 6 | | | | ID | Title | Description |
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| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol | Normal range for this adrenal parameter was 85.6 to 618.2 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline through Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH) | Normal range for this parameter was 0.35 to 5.5 mIU/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | mIU/L | | Baseline through Month 6 | | | | ID | Title | Description |
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| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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| Secondary | Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin | Normal range for this parameter was 28 to 146 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. | Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received. | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline through Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Treatment I: (DR-102) | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles | | OG001 | Treatment II | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
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