Skip to main content
OpenTrials
Completed

NCT Number: NCT01252186

A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemostasis Cardiovascular Diseases Embolism and Thrombosis Oral Contraceptive Thrombosis Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Teva Investigational Site, Cagliari, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premenopausal, non-pregnant, non-lactating women age 18-40 years old
  • Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
  • Regular spontaneous menstrual cycle
  • Others as dictated by FDA-approved protocol

Exclusion criteria

  • Any condition which contraindicates the use of combination oral contraceptives
  • Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
  • Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
  • Others as dictated by FDA-approved protocol

Treatment and study plan

91-day Levonorgestrel Oral Contraceptive

Drug

91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.

Other names: Seasonique®

28-day Levonorgestrel Oral Contraceptive

Drug

21 combination tablets containing 150 µg LNG/30 µg EE.

Other names: Minidril®

28-day Desogestrel Oral Contraceptive

Drug

21 combination tablets containing 150 µg DSG/30 µg EE.

Other names: Marvelon®

Primary outcomes

  1. Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels

    Time frame: Baseline to Month 6

    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.

Secondary outcomes

  1. Change From Baseline to End of Month 6 in D-dimer

    Time frame: Baseline to Month 6

    D-dimer is the degradation product of cross-linked fibrin and is a marker of thrombin and fibrin formation and turnover.

  2. Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex

    Time frame: Baseline to Month 6

    The plasmin-antiplasmin (PAP) complex is a marker of thrombin and fibrin formation and turnover.

  3. Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)

    Time frame: Baseline to Month 6

    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.

  4. Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)

    Time frame: Baseline to Month 6

    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.

  5. Change From Baseline to End of Month 6 in Fibrinogen

    Time frame: Baseline to Month 6

    Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots.

  6. Change From Baseline to End of Month 6 in Plasminogen

    Time frame: Baseline to Month 6

    Plasminogen is the precursor of plasmin, which lyses fibrin clots.

  7. Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)

    Time frame: Baseline to Month 6

    Tissue plasminogen activator catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for the breakdown of blood clots.

  8. Change From Baseline to End of Month 6 in Factor II

    Time frame: Baseline to Month 6

    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.

  9. Change From Baseline to End of Month 6 in Factor VII

    Time frame: Baseline to Month 6

    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.

  10. Change From Baseline to End of Month 6 in Factor VIII

    Time frame: Baseline to Month 6

    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.

  11. Change From Baseline to End of Month 6 in Antithrombin

    Time frame: Baseline to Month 6

    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.

  12. Change From Baseline to End of Month 6 in Protein C Activity

    Time frame: Baseline to Month 6

    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.

  13. Change From Baseline to End of Month 6 in Protein C Antigen

    Time frame: Baseline to Month 6

    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.

  14. Change From Baseline to End of Month 6 in Free Protein S

    Time frame: Baseline to Month 6

    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.

  15. Change From Baseline to End of Month 6 in Total Protein S

    Time frame: Baseline to Month 6

    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.

  16. Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)

    Time frame: Baseline to Month 6

    Tissue Factor Pathway Inhibitor (TFPI) is an anti-coagulation protein that binds to activated protein X.

  17. Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)

    Time frame: Baseline top Month 6

  18. Change From Baseline to End of Month 6 in Total Cortisol

    Time frame: Baseline to Month 6

  19. Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin

    Time frame: Baseline to Month 6

  20. Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)

    Time frame: Baseline to Month 6

Sponsors and collaborators

Lead sponsor

Teva Women's Health

Industry

Registry information

Official study title

A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of a 91-Day Extended Cycle Oral Contraceptive Regimen, Compared to Two 28-day Standard Oral Contraceptive Regimens, on Hemostatic Parameters in Healthy Women.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2010
Registry last updated
Mar 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.