A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
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| ClinicalTrials.gov Identifier: NCT01252186 |
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Recruitment Status :
Completed
First Posted : December 2, 2010
Results First Posted : March 13, 2015
Last Update Posted : March 13, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hemostasis Oral Contraceptive | Drug: 91-day Levonorgestrel Oral Contraceptive Drug: 28-day Levonorgestrel Oral Contraceptive Drug: 28-day Desogestrel Oral Contraceptive | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 265 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official 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. |
| Study Start Date : | November 2010 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2011 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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® |
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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.
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Drug: 28-day Levonorgestrel Oral Contraceptive
21 combination tablets containing 150 µg LNG/30 µg EE.
Other Name: Minidril® |
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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.
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Drug: 28-day Desogestrel Oral Contraceptive
21 combination tablets containing 150 µg DSG/30 µg EE.
Other Name: Marvelon® |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 ]
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252186
| United States, California | |
| Teva Investigational Site | |
| San Diego, California, United States, 92103 | |
| Teva Investigational Site | |
| San Diego, California, United States, 92108 | |
| Teva Investigational Site | |
| San Diego, California, United States, 92123 | |
| United States, District of Columbia | |
| Teva Investigational Site | |
| Washington, District of Columbia, United States, 20036 | |
| United States, Florida | |
| Teva Investigational Site | |
| Miami, Florida, United States, 33186 | |
| Teva Investigational Site | |
| West Palm Beach, Florida, United States, 33409 | |
| United States, Georgia | |
| Teva Investigational Site | |
| Sandy Springs, Georgia, United States, 30328 | |
| United States, New Jersey | |
| Teva Investigational Site | |
| Edison, New Jersey, United States, 08817 | |
| Teva Investigational Site | |
| Plainsboro, New Jersey, United States, 08536 | |
| United States, New Mexico | |
| Teva Investigational Site | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Teva Investigational Site | |
| Port Jefferson, New York, United States, 11777 | |
| Teva Investigational Site | |
| Rochester, New York, United States, 14609 | |
| United States, North Carolina | |
| Teva Investigational Site | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Pennsylvania | |
| Teva Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19114 | |
| Teva Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15206 | |
| Teva Investigational Site | |
| Uniontown, Pennsylvania, United States, 15401 | |
| United States, Texas | |
| Teva Investigational Site | |
| Dallas, Texas, United States, 75234 | |
| Teva Investigational Site | |
| Houston, Texas, United States, 77054 | |
| Teva Investigational Site | |
| San Antonio, Texas, United States, 78258 | |
| United States, Virginia | |
| Teva Investigational Site | |
| Richmond, Virginia, United States, 23233 | |
| United States, Washington | |
| Teva Investigational Site | |
| Seattle, Washington, United States, 98105 | |
| Italy | |
| Teva Investigational Site | |
| Cagliari, Italy, 09124 | |
| Teva Investigational Site | |
| Modena, Italy, 41100 | |
| Teva Investigational Site | |
| Pavia, Italy, 27100 | |
| Study Chair: | Teva Women's Health Research Protocol Chair | Teva Women's Health Research |
| Responsible Party: | Teva Women's Health |
| ClinicalTrials.gov Identifier: | NCT01252186 |
| Other Study ID Numbers: |
PSE-HSP-203 2010-023215-34 ( EudraCT Number ) |
| First Posted: | December 2, 2010 Key Record Dates |
| Results First Posted: | March 13, 2015 |
| Last Update Posted: | March 13, 2015 |
| Last Verified: | February 2015 |
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Contraception Hemostasis Blood Coagulation |
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Contraceptive Agents Levonorgestrel Desogestrel Contraceptives, Oral Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Hormonal |
Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral, Hormonal Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |