Clinical trial NCT01252186: A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemostasis
Oral Contraceptive
Keywords: Contraception
Hemostasis
Blood Coagulation
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels
timeFrame: Baseline to Month 6
Secondary outcomes:
measure: Change From Baseline to End of Month 6 in D-dimer
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Fibrinogen
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Plasminogen
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Factor II
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Factor VII
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Factor VIII
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Antithrombin
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Protein C Activity
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Protein C Antigen
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Free Protein S
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Total Protein S
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)
timeFrame: Baseline top Month 6
measure: Change From Baseline to End of Month 6 in Total Cortisol
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin
timeFrame: Baseline to Month 6
measure: Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)
timeFrame: Baseline to Month 6
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Teva Investigational Site
state: California
city: San Diego
country: United States
facility: Teva Investigational Site
state: California
city: San Diego
country: United States
facility: Teva Investigational Site
state: California
city: Washington
country: United States
facility: Teva Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: Teva Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Teva Investigational Site
state: Florida
city: Sandy Springs
country: United States
facility: Teva Investigational Site
state: Georgia
city: Edison
country: United States
facility: Teva Investigational Site
state: New Jersey
city: Plainsboro
country: United States
facility: Teva Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Teva Investigational Site
state: New Mexico
city: Port Jefferson
country: United States
facility: Teva Investigational Site
state: New York
city: Rochester
country: United States
facility: Teva Investigational Site
state: New York
city: Winston Salem
country: United States
facility: Teva Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Teva Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Teva Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Teva Investigational Site
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site
state: Texas
city: Richmond
country: United States
facility: Teva Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Teva Investigational Site
state: Washington
city: Cagliari
country: Italy
facility: Teva Investigational Site
city: Modena
country: Italy
facility: Teva Investigational Site
city: Pavia
country: Italy
facility: Teva Investigational Site
Study officials:
affiliation: Teva Women's Health Research
name: Teva Women's Health Research Protocol Chair
role: STUDY_CHAIR
References: