A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
- Conditions
- HemostasisOral Contraceptive
- Interventions
- Registration Number
- NCT01388491
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 293
- 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
- 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
- Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders
- Others as dictated by FDA-approved protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment I: (DR-102) desogestrel/ethinyl estradiol and ethinyl estradiol 21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles Treatment II desogestrel/ethinyl estradiol 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
- Primary Outcome Measures
Name Time Method Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels Baseline through Month 6 Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
- Secondary Outcome Measures
Name Time Method Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity Baseline through Month 6 The normal range for this hemostatic parameter was 70% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin Baseline through Month 6 Normal range for this adrenal parameter was 1906.448 to 4520.504 mg/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol Baseline through Month 6 Normal range for this adrenal parameter was 85.6 to 618.2 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer Baseline through Month 6 Normal range for this hemostatic parameter was 0 to 729 mcg/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen Baseline through Month 6 The normal range for this hemostatic parameter was 50% to 147%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin Baseline through Month 6 Normal range for this hemostatic parameter was 75% to 130%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII Baseline through Month 6 Normal range for this hemostatic parameter was 60% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH) Baseline through Month 6 Normal range for this parameter was 0.35 to 5.5 mIU/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity Baseline through Month 6 Normal range for this hemostatic parameter was 70% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII Baseline through Month 6 Normal range for this hemostatic parameter was 50% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin Baseline through Month 6 Normal range for this parameter was 28 to 146 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance Baseline through Month 6 This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 2.00 to 3.36. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance Baseline through Month 6 This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 0.32 to 1.79. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Trial Locations
- Locations (27)
Teva Investigational Site 30012
🇮🇹Catania, Italy
Teva Investigational Site 80017
🇮🇱Modi'in, Israel
Teva Investigational Site 30016
🇮🇹Siena, Italy
Teva Investigational Site 80013
🇮🇱Givataim, Israel
Teva Investigational Site 32061
🇩🇪Magdeburg, Germany
Teva Investigational Site 80018
🇮🇱Tel-Aviv, Israel
Teva Investigational Site 30007
🇮🇹Pisa, Italy
Teva Investigational Site 80015
🇮🇱Haifa, Israel
Teva Investigational Site 80016
🇮🇱Tel-Aviv, Israel
Teva Investigational Site 80014
🇮🇱RishonLe'zio, Israel
Teva Investigational Site 32064
🇩🇪Essen, Germany
Teva Investigational Site 31015
🇪🇸Barcelona, Spain
Teva Investigational Site 30014
🇮🇹Brescia, Italy
Teva Investigational Site 30009
🇮🇹Cagliari, Italy
Teva Investigational Site 30013
🇮🇹Napoli, Italy
Teva Investigational Site 32065
🇩🇪Frankfurt, Germany
Teva Investigational Site 32062
🇩🇪Hamburg, Germany
Teva Investigational Site 32066
🇩🇪Frankfurt am Main, Germany
Teva Investigational Site 32063
🇩🇪Hamburg, Germany
Teva Investigational Site 30010
🇮🇹Pavia, Italy
Teva Investigational Site 31017
🇪🇸Barcelona, Spain
Teva Investigational Site 31012
🇪🇸Lugo, Spain
Teva Investigational Site 31014
🇪🇸Barcelona, Spain
Teva Investigational Site 31009
🇪🇸Vitoria-Gasteiz, Spain
Teva Investigational Site 31010
🇪🇸Madrid, Spain
Teva Investigational Site 31016
🇪🇸Gava, Barcelona, Spain
Teva Investigational Site 31011
🇪🇸Madrid, Spain