Phase 2
N=265
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
Hemostasis · Oral Contraceptive
Bottom Line
View on ClinicalTrials.gov: NCT01252186 ↗Enrolled (actual)
265
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels — 169.53; 157.99; 592.29 pmol/L — p=0.958
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 91-day Levonorgestrel Oral Contraceptive (Drug); 28-day Levonorgestrel Oral Contraceptive (Drug); 28-day Desogestrel Oral Contraceptive (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Teva Women's Health
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels |
169.53; 157.99; 592.29 | 0.958 |
| SECONDARY Change From Baseline to End of Month 6 in D-dimer |
86.74; 72.43; 158.05 | 0.745 |
| SECONDARY Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex |
10.72; -6.42; 107.81 | 0.782 |
| SECONDARY Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC) |
-0.12; -0.15; -0.27 | 0.428 |
| SECONDARY Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC) |
0.38; 0.37; 0.57 | 0.868 |
| SECONDARY Change From Baseline to End of Month 6 in Fibrinogen |
0.12; 0.22; -0.04 | 0.317 |
| SECONDARY Change From Baseline to End of Month 6 in Plasminogen |
0.04; 0.04; 0.04 | 0.331 |
| SECONDARY Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA) |
-0.91; -1.48; -9.3 | 0.194 |
| SECONDARY Change From Baseline to End of Month 6 in Factor II |
6.89; 7.98; 8.57 | 0.648 |
| SECONDARY Change From Baseline to End of Month 6 in Factor VII |
14.27; 22.98; 43.22 | 0.405 |
| SECONDARY Change From Baseline to End of Month 6 in Factor VIII |
-3.23; 0.08; 5.53 | 0.425 |
| SECONDARY Change From Baseline to End of Month 6 in Antithrombin |
2.36; -0.05; -0.83 | 0.088 |
| SECONDARY Change From Baseline to End of Month 6 in Protein C Activity |
-6.15; -4.39; -2.41 | 0.631 |
| SECONDARY Change From Baseline to End of Month 6 in Protein C Antigen |
12.83; 11.97; 10.00 | 0.783 |
| SECONDARY Change From Baseline to End of Month 6 in Free Protein S |
2.96; 4.62; -18.2 | 0.572 |
| SECONDARY Change From Baseline to End of Month 6 in Total Protein S |
-11.06; -11.48; -21.59 | 0.841 |
| SECONDARY Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI) |
4.65; 2.54; -1.34 | 0.227 |
| SECONDARY Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH) |
-0.22; 0.10; 0.22 | 0.076 |
| SECONDARY Change From Baseline to End of Month 6 in Total Cortisol |
217.94; 262.40; 227.68 | 0.190 |
| SECONDARY Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin |
576.33; 563.85; 634.64 | 0.843 |
| SECONDARY Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG) |
34.87; 30.85; 165.01 | 0.731 |
Summary
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT01252186). 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.