This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
265
91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.
21 combination tablets containing 150 µg LNG/30 µg EE.
21 combination tablets containing 150 µg DSG/30 µg EE.
Teva Investigational Site
San Diego, California, United States
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Teva Investigational Site
San Diego, California, United States
Teva Investigational Site
San Diego, California, United States
Teva Investigational Site
Washington D.C., District of Columbia, United States
Teva Investigational Site
Miami, Florida, United States
Teva Investigational Site
West Palm Beach, Florida, United States
Teva Investigational Site
Sandy Springs, Georgia, United States
Teva Investigational Site
Edison, New Jersey, United States
Teva Investigational Site
Plainsboro, New Jersey, United States
Teva Investigational Site
Albuquerque, New Mexico, United States
...and 14 more locations
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Fibrinogen
Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots.
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Plasminogen
Plasminogen is the precursor of plasmin, which lyses fibrin clots.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
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.
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)
Time frame: Baseline top Month 6
Change From Baseline to End of Month 6 in Total Cortisol
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)
Time frame: Baseline to Month 6