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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier:
NCT01252186
First received: November 30, 2010
Last updated: February 27, 2015
Last verified: February 2015

November 30, 2010
February 27, 2015
November 2010
December 2011   (final data collection date for primary outcome measure)
Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]
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.
Change from baseline to end of month 6 in Prothrombin fragment 1+2 levels. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01252186 on ClinicalTrials.gov Archive Site
  • Change From Baseline to End of Month 6 in D-dimer [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]
    D-dimer is the degradation product of cross-linked fibrin and is a marker of thrombin and fibrin formation and turnover.
  • Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    The plasmin-antiplasmin (PAP) complex is a marker of thrombin and fibrin formation and turnover.
  • 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 ] [ Designated as safety issue: Yes ]

    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.

  • 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 ] [ Designated as safety issue: Yes ]

    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.

  • Change From Baseline to End of Month 6 in Fibrinogen [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots.
  • Change From Baseline to End of Month 6 in Plasminogen [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Plasminogen is the precursor of plasmin, which lyses fibrin clots.
  • Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA) [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Tissue plasminogen activator catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for the breakdown of blood clots.
  • Change From Baseline to End of Month 6 in Factor II [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]
    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.
  • Change From Baseline to End of Month 6 in Factor VII [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]

    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.

  • Change From Baseline to End of Month 6 in Factor VIII [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]

    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.

  • Change From Baseline to End of Month 6 in Antithrombin [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]

    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.

  • Change From Baseline to End of Month 6 in Protein C Activity [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]

    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.

  • Change From Baseline to End of Month 6 in Protein C Antigen [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]

    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.

  • Change From Baseline to End of Month 6 in Free Protein S [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]

    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.

  • Change From Baseline to End of Month 6 in Total Protein S [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]

    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.

  • Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI) [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Tissue Factor Pathway Inhibitor (TFPI) is an anti-coagulation protein that binds to activated protein X.
  • Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH) [ Time Frame: Baseline top Month 6 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Month 6 in Total Cortisol [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG) [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Month 6 in D-dimer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Plasmin-Antiplasmin complex [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in APTT and ETP based activated protein-C resistance (APC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Month 6 in Fibrinogen [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Antithrombin [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Tissue Factor Pathway Inhibitior (TFPI) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in total cortisol and corticosteroid binding globulin (CBG) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Hemostasis
  • Oral Contraceptive
  • Drug: 91-day Levonorgestrel Oral Contraceptive
    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 Name: Seasonique®
  • Drug: 28-day Levonorgestrel Oral Contraceptive
    21 combination tablets containing 150 µg LNG/30 µg EE.
    Other Name: Minidril®
  • Drug: 28-day Desogestrel Oral Contraceptive
    21 combination tablets containing 150 µg DSG/30 µg EE.
    Other Name: Marvelon®
  • Experimental: 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.
    Intervention: Drug: 91-day Levonorgestrel Oral Contraceptive
  • Active Comparator: 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.
    Intervention: Drug: 28-day Levonorgestrel Oral Contraceptive
  • Active Comparator: 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.
    Intervention: Drug: 28-day Desogestrel Oral Contraceptive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
265
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Italy
 
NCT01252186
PSE-HSP-203, 2010-023215-34
No
Not Provided
Not Provided
Teva Women's Health
Teva Women's Health
Not Provided
Study Chair: Teva Women's Health Research Protocol Chair Teva Women's Health Research
Teva Pharmaceutical Industries
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP