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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier:
NCT01252186
First received: November 30, 2010
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemostasis
Oral Contraceptive
 Drug: Levonorgestrel/ethinyl estradiol and ethinyl estradiol
Drug: Levonorgestrel/ethinyl estradiol 0.15/0.03 mg.
Drug: Desogestrel/ethinyl estradiol 0.15/0.03 mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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.

Resource links provided by NLM:

MedlinePlus related topics: Women's Health
U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change from baseline to end of month 6 in Prothrombin fragment 1+2 levels. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline to end of month 6 in D-dimer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Plasmin-Antiplasmin complex [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in activated partial thromboplastin time (APTT) and etoposide (ETP) based activated protein-C resistance (APC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Fibrinogen [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Tissue Plasminogen Activator (t-PA) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Antithrombin [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Tissue Factor Pathway Inhibitor (TFPI) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in sex hormone binding globulin (SHBG) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in total cortisol and corticosteroid binding globulin (CBG) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in thyroid stimulating hormone (TSH) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 265
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 91-day Levonorgestrel Oral Contraceptive Drug: Levonorgestrel/ethinyl estradiol and ethinyl estradiol
Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.
Other Name: Seasonique®
Active Comparator: 28-day Levonorgestrel Oral Contraceptive Drug: Levonorgestrel/ethinyl estradiol 0.15/0.03 mg.
1 tablet daily
Other Name: Minidril®
Active Comparator: 28-day Desogestrel Oral Contraceptive Drug: Desogestrel/ethinyl estradiol 0.15/0.03 mg
1 Tablet Daily
Other Name: Marvelon®

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252186

Locations
United States, California
Teva Investigational Site
San Diego, California, United States, 92108
Teva Investigational Site
San Diego, California, United States, 92123
Teva Investigational Site
San Diego, California, United States, 92103
United States, District of Columbia
Teva Investigational Site
Washington, District of Columbia, United States, 20036
United States, Florida
Teva Investigational Site
Miami, Florida, United States, 33186
Teva Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Teva Investigational Site
Sandy Springs, Georgia, United States, 30328
United States, New Jersey
Teva Investigational Site
Edison, New Jersey, United States, 08817
Teva Investigational Site
Plainsboro, New Jersey, United States, 08536
United States, New Mexico
Teva Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Teva Investigational Site
Port Jefferson, New York, United States, 11777
Teva Investigational Site
Rochester, New York, United States, 14609
United States, North Carolina
Teva Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Teva Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Teva Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
Teva Investigational Site
Uniontown, Pennsylvania, United States, 15401
United States, Texas
Teva Investigational Site
Dallas, Texas, United States, 75234
Teva Investigational Site
Houston, Texas, United States, 77054
Teva Investigational Site
San Antonio, Texas, United States, 78258
United States, Virginia
Teva Investigational Site
Richmond, Virginia, United States, 23233
United States, Washington
Teva Investigational Site
Seattle, Washington, United States, 98105
Italy
Teva Investigational Site
Cagliari, Italy, 09124
Teva Investigational Site
Modena, Italy, 41100
Teva Investigational Site
Pavia, Italy, 27100
Sponsors and Collaborators
Teva Women's Health
Investigators
Study Chair: Teva Women's Health Research Protocol Chair Teva Women's Health Research
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier: NCT01252186     History of Changes
Other Study ID Numbers: PSE-HSP-203, 2010-023215-34
Study First Received: November 30, 2010
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Contraception
Hemostasis
Blood Coagulation

Additional relevant MeSH terms:
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Desogestrel
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Hemostatics
Reproductive Control Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Coagulants
Hematologic Agents
Contraceptives, Oral, Synthetic
Progestins

ClinicalTrials.gov processed this record on June 17, 2013