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A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemostasis; Oral Contraceptive

Intervention: 91-day Levonorgestrel Oral Contraceptive (Drug); 28-day Levonorgestrel Oral Contraceptive (Drug); 28-day Desogestrel Oral Contraceptive (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Teva Women's Health

Official(s) and/or principal investigator(s):
Teva Women's Health Research Protocol Chair, Study Chair, Affiliation: Teva Women's Health Research

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels

Secondary outcome:

Change From Baseline to End of Month 6 in D-dimer

Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex

Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)

Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)

Change From Baseline to End of Month 6 in Fibrinogen

Change From Baseline to End of Month 6 in Plasminogen

Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)

Change From Baseline to End of Month 6 in Factor II

Change From Baseline to End of Month 6 in Factor VII

Change From Baseline to End of Month 6 in Factor VIII

Change From Baseline to End of Month 6 in Antithrombin

Change From Baseline to End of Month 6 in Protein C Activity

Change From Baseline to End of Month 6 in Protein C Antigen

Change From Baseline to End of Month 6 in Free Protein S

Change From Baseline to End of Month 6 in Total Protein S

Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)

Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)

Change From Baseline to End of Month 6 in Total Cortisol

Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin

Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

Locations and Contacts

Teva Investigational Site, Cagliari 09124, Italy

Teva Investigational Site, Modena 41100, Italy

Teva Investigational Site, Pavia 27100, Italy

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, 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

Additional Information

Starting date: November 2010
Last updated: February 27, 2015

Page last updated: August 23, 2015

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