| Primary | Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels | Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis. | Per-Protocol (PP) Population included all data from ITT participants obtained prior to experiencing major protocol violations. | Posted | | Least Squares Mean | Standard Error | pmol/L | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000169.53± 155.15
- OG001157.99± 150.11
- OG002592.29± 160.32
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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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| The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction. | Mixed Models Analysis | | 0.958 | | Treatment Difference | -11.54 | | | 2-Sided | 95 | -440.1 | 417.0 | | | Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel) | Yes | Non-Inferiority or Equivalence | A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L). |
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| Secondary | Change From Baseline to End of Month 6 in D-dimer | D-dimer is the degradation product of cross-linked fibrin and is a marker of thrombin and fibrin formation and turnover. | | Posted | | Least Squares Mean | Standard Error | ng/mL | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex | The plasmin-antiplasmin (PAP) complex is a marker of thrombin and fibrin formation and turnover. | | Posted | | Least Squares Mean | Standard Error | ng/mL | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC) | The APC resistance assay is a clotting test that measures the ratio of APTT clotting times in the presence and absence of a standard amount of exogenous APC. APC resistance is calculated as the ratio of the clotting time after APC addition over the clotting time with no APC addition. APC resistance is defined as a poor anticoagulant response of plasma to APC (minimal prolongation of the APTT) and a correspondingly low ratio. | Per-protocol population with available data | Posted | | Least Squares Mean | Standard Error | ratio | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive |
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| Secondary | Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC) | This assay is based on measurement of the effect of activated protein C on the endogenous thrombin potential, the time integral of thrombin generation initiated in plasma through the extrinsic coagulation pathway. The APC resistance assay measures the ratio of endogenous thrombin potential in the presence and absence of a standard amount of exogenous APC. APC resistance is calculated as the ratio of EPT after APC addition over the EPT with no APC addition. APC resistance is defined as a poor anticoagulant response of plasma to APC (less inhibition of thrombin formation) and a correspondingly higher ratio. | | Posted | | Least Squares Mean | Standard Error | ratio | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | |
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| Secondary | Change From Baseline to End of Month 6 in Fibrinogen | Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots. | | Posted | | Least Squares Mean | Standard Error | g/L | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Plasminogen | Plasminogen is the precursor of plasmin, which lyses fibrin clots. | | Posted | | Least Squares Mean | Standard Error | g/L | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA) | Tissue plasminogen activator catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for the breakdown of blood clots. | | Posted | | Least Squares Mean | Standard Error | µg/L | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Factor II | Clotting factor II, also called prothrombin, functions in blood coagulation. Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults. | | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Factor VII | Clotting factor VII, also called proconvertin or autoprothrombin I, functions in blood coagulation. Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults. | | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Factor VIII | Clotting factor VIII, also known as anti-hemophilic factor (AHF), functions in blood coagulation by stabilizing fibrin clots. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%.for adults. | | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Antithrombin | Antithrombin is a protein in the blood that naturally blocks blood clots from forming. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 80% to 130%.for adults. | | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Protein C Activity | Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% for adults. | | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | |
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| Secondary | Change From Baseline to End of Month 6 in Protein C Antigen | Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% in adults. | | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | |
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| Secondary | Change From Baseline to End of Month 6 in Free Protein S | Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with Protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men. | | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive |
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| Secondary | Change From Baseline to End of Month 6 in Total Protein S | Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with activated protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men. | | Posted | | Least Squares Mean | Standard Error | percentage of normal | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive |
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| Secondary | Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI) | Tissue Factor Pathway Inhibitor (TFPI) is an anti-coagulation protein that binds to activated protein X. | | Posted | | Least Squares Mean | Standard Error | ng/mL | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH) | | Per-protocol population with available data | Posted | | Least Squares Mean | Standard Error | mIU/L | | Baseline top Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Total Cortisol | | | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline to Month 6 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin | | Per-protocol population with available data | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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| Secondary | Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG) | | Per-protocol population with available data | Posted | | Least Squares Mean | Standard Error | mIU/L | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | 91-day Levonorgestrel Oral Contraceptive | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. | | OG001 | 28-day Levonorgestrel Oral Contraceptive | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. | | OG002 | 28-day Desogestrel Oral Contraceptive | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
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