Phase 2
N=293
A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
Hemostasis · Oral Contraceptive
Bottom Line
View on ClinicalTrials.gov: NCT01388491 ↗Enrolled (actual)
293
Serious AEs
0.4%
Results posted
Nov 2013
Primary outcome: Primary: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels — 45.0; 56.8 pmol/L — p=0.5892
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- desogestrel/ethinyl estradiol and ethinyl estradiol (Drug); desogestrel/ethinyl estradiol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels |
45.0; 56.8 | 0.5892 |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer |
16.4; 13.4 | 0.839 |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen |
-11.4; -6.6 | 0.0021 sig |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity |
16.3; 13.0 | 0.2312 |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin |
-1.6; -3.2 | 0.3440 |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity |
3.3; 3.0 | 0.2522 |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII |
17.9; 15.1 | 0.0143 sig |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII |
11.1; 10.6 | 0.8507 |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance |
-0.3; -0.4 | 0.0459 sig |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance |
0.8; 0.7 | 0.0318 sig |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin |
4083.3; 3721.8 | 0.1148 |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol |
239.0; 230.8 | 0.7136 |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH) |
0.2; 0.3 | 0.3903 |
| SECONDARY Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin |
163.4; 149.1 | 0.1731 |
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.
Eligibility Criteria
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
- Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders
- Others as dictated by FDA-approved protocol
Data sourced from ClinicalTrials.gov (NCT01388491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.