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.
2 other identifiers
interventional
265
2 countries
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2010
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 30, 2010
CompletedFirst Posted
Study publicly available on registry
December 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
March 13, 2015
CompletedMarch 13, 2015
February 1, 2015
1.1 years
November 30, 2010
February 27, 2015
February 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels
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.
Baseline to Month 6
Secondary Outcomes (20)
Change From Baseline to End of Month 6 in D-dimer
Baseline to Month 6
Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex
Baseline to Month 6
Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)
Baseline to Month 6
Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)
Baseline to Month 6
Change From Baseline to End of Month 6 in Fibrinogen
Baseline to Month 6
- +15 more secondary outcomes
Study Arms (3)
91-day Levonorgestrel Oral Contraceptive
EXPERIMENTALParticipants 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.
28-day Levonorgestrel Oral Contraceptive
ACTIVE COMPARATORParticipants 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.
28-day Desogestrel Oral Contraceptive
ACTIVE COMPARATORParticipants 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.
Interventions
91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.
21 combination tablets containing 150 µg LNG/30 µg EE.
21 combination tablets containing 150 µg DSG/30 µg EE.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Teva Investigational Site
San Diego, California, 92103, United States
Teva Investigational Site
San Diego, California, 92108, United States
Teva Investigational Site
San Diego, California, 92123, United States
Teva Investigational Site
Washington D.C., District of Columbia, 20036, United States
Teva Investigational Site
Miami, Florida, 33186, United States
Teva Investigational Site
West Palm Beach, Florida, 33409, United States
Teva Investigational Site
Sandy Springs, Georgia, 30328, United States
Teva Investigational Site
Edison, New Jersey, 08817, United States
Teva Investigational Site
Plainsboro, New Jersey, 08536, United States
Teva Investigational Site
Albuquerque, New Mexico, 87102, United States
Teva Investigational Site
Port Jefferson, New York, 11777, United States
Teva Investigational Site
Rochester, New York, 14609, United States
Teva Investigational Site
Winston-Salem, North Carolina, 27103, United States
Teva Investigational Site
Philadelphia, Pennsylvania, 19114, United States
Teva Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Teva Investigational Site
Uniontown, Pennsylvania, 15401, United States
Teva Investigational Site
Dallas, Texas, 75234, United States
Teva Investigational Site
Houston, Texas, 77054, United States
Teva Investigational Site
San Antonio, Texas, 78258, United States
Teva Investigational Site
Richmond, Virginia, 23233, United States
Teva Investigational Site
Seattle, Washington, 98105, United States
Teva Investigational Site
Cagliari, 09124, Italy
Teva Investigational Site
Modena, 41100, Italy
Teva Investigational Site
Pavia, 27100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Study Officials
- STUDY CHAIR
Teva Women's Health Research Protocol Chair
Teva Women's Health Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2010
First Posted
December 2, 2010
Study Start
November 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 13, 2015
Results First Posted
March 13, 2015
Record last verified: 2015-02