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Last Updated: Jul 11, 2008 - 11:26:39 AM

                                                                                                                              

Study of Safety and Efficacy of an Oral Contraceptive


By Clinical Trials


Jan 19, 2007 - 8:53:15 PM


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Study of Safety and Efficacy of an Oral Contraceptive

This study is currently recruiting patients.
Verified by Warner Chilcott January 2007

Sponsored by: Warner Chilcott
Information provided by: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00391807

Purpose

This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
Condition Intervention Phase
Contraception
  Drug: Norethindrone acetate/ethinyl estradiol
 Phase III

MedlinePlus  consumer health information 

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

Further study details as provided by Warner Chilcott:
Primary Outcomes: Pregnancy rate among women 18 to 35 years old, expressed in terms of the; Pearl Index defined as the number of pregnancies per 100 women-years of treatment.
Secondary Outcomes: Descriptive parameters of bleeding/spotting, safety and tolerability.
Expected Total Enrollment:  1600

Study start: November 2006;  Expected completion: August 2008
Last follow-up: June 2008;  Data entry closure: July 2008

Eligibility

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Healthy Women
  • Age 18-45
  • At risk for pregnancy
  • History of regular cycles

Exclusion Criteria:

  • Contraindications for use of hormonal contraception
  • Conditions which affect the absorption or metabolism of steroid hormones
  • BMI > 35

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00391807

Cathleen Platt      973-442-3243    cplatt@wcrx.com
Michelle Brown      973-442-3261    mbrown@wcrx.com

Arizona
      Warner Chilcott Investigational Site, Phoenix,  Arizona,  85014,  United States; Recruiting

      Warner Chilcott Investigational Site, Phoenix,  Arizona,  85050,  United States; Recruiting

      Warner Chilcott Investigational Site, Phoenix,  Arizona,  85015,  United States; Recruiting

      Warner Chilcott Investigational Site, Tucson,  Arizona,  85712,  United States; Recruiting

      Warner Chilcott Investigational Site, Phoenix,  Arizona,  85032,  United States; Recruiting

      Warner Chilcott Investigational Site, Tempe,  Arizona,  85283,  United States; Recruiting

      Warner Chilcott Investigational Site, Phoenix,  Arizona,  85031,  United States; Recruiting

California
      Warner Chilcott Investigational Site, San Diego,  California,  92108,  United States; Recruiting

      Warner Chilcott Investigational Site, San Diego,  California,  92103,  United States; Recruiting

      Warner Chilcott Investigational Site, Carmichael,  California,  95608,  United States; Recruiting

Colorado
      Warner Chilcott Investigational Site, Denver,  Colorado,  80218,  United States; Recruiting

Florida
      Warner Chilcott Investigational Site, West Palm Beach,  Florida,  33409,  United States; Recruiting

      Warner Chilcott Investigational Site, Boynton Beach,  Florida,  33437,  United States; Recruiting

      Warner Chilcott Investigational Site, Jacksonville,  Florida,  32207,  United States; Recruiting

      Warner Chilcott Investigational Site, Clearwater,  Florida,  33759,  United States; Recruiting

      Warner Chilcott Investigational Site, Plantation,  Florida,  33324,  United States; Recruiting

      Warner Chilcott Investigational Site, St. Petersburg,  Florida,  33709,  United States; Recruiting

      Warner Chilcott Investigational Site, New Port Richey,  Florida,  34652,  United States; Recruiting

      Warner Chilcott Investigational Site, Longwood,  Florida,  32779,  United States; Recruiting

      Warner Chilcott Investigational Site, West Palm Beach,  Florida,  33401,  United States; Recruiting

      Warner Chilcott Investigational Site, Miami,  Florida,  33143,  United States; Recruiting

      Warner Chilcott Investigational Site, Miami,  Florida,  33186,  United States; Recruiting

      Warner Chilcott Investigational Site, Leesburg,  Florida,  34748,  United States; Recruiting

Georgia
      Warner Chilcott Investigational Site, Sandy Springs,  Georgia,  30328,  United States; Recruiting

      Warner Chilcott Investigational Site, Roswell,  Georgia,  30075,  United States; Recruiting

Illinois
      Warner Chilcott Investigational Site, Champaign,  Illinois,  61820,  United States; Recruiting

      Warner Chilcott Investigational Site, Peoria,  Illinois,  61615,  United States; Recruiting

Kentucky
      Warner Chilcott Investigational Site, Louisville,  Kentucky,  40202,  United States; Recruiting

      Warner Chilcott Investigational Site, Louisville,  Kentucky,  40291,  United States; Recruiting

      Warner Chilcott Investigational Site, Lexington,  Kentucky,  40509,  United States; Recruiting

New Jersey
      Warner Chilcott Investigational Site, Berlin,  New Jersey,  08009,  United States; Recruiting

      Warner Chilcott Investigational Site, Moorestown,  New Jersey,  08057,  United States; Recruiting

      Warner Chilcott Investigational Site, Lawrenceville,  New Jersey,  08648,  United States; Recruiting

New Mexico
      Warner Chilcott Investigational Site, Albuquerque,  New Mexico,  87102,  United States; Recruiting

North Carolina
      Warner Chilcott Investigational Site, Winston-Salem,  North Carolina,  27103,  United States; Recruiting

      Warner Chilcott Investigational Site, Raleigh,  North Carolina,  27609,  United States; Recruiting

      Warner Chilcott Investigational Site, Raleigh,  North Carolina,  27612,  United States; Recruiting

      Warner Chilcott Investigational Site, New Bern,  North Carolina,  28562,  United States; Recruiting

Ohio
      Warner Chilcott Investigational Site, Cleveland,  Ohio,  44122,  United States; Recruiting

      Warner Chilcott Investigational Site, Columbus,  Ohio,  43213,  United States; Recruiting

Oklahoma
      Warner Chilcott Investigational Site, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting

Oregon
      Warner Chilcott Investigational Site, Portland,  Oregon,  97239,  United States; Recruiting

      Warner Chilcott Investigational Site, Portland,  Oregon,  97210,  United States; Recruiting

Pennsylvania
      Warner Chilcott Investigational Site, Pittsburgh,  Pennsylvania,  15206,  United States; Recruiting

      Warner Chilcott Investigational Site, Pottstown,  Pennsylvania,  19464-3224,  United States; Recruiting

      Warner Chilcott Investigational Site, Philadelphia,  Pennsylvania,  19114,  United States; Recruiting

South Carolina
      Warner Chilcott Investigational Site, Charleston,  South Carolina,  29401,  United States; Recruiting

      Warner Chilcott Investigational Site, Charleston,  South Carolina,  29425,  United States; Recruiting

      Warner Chilcott Investigational Site, Columbia,  South Carolina,  29201,  United States; Recruiting

      Warner Chilcott Investigational Site, Greenville,  South Carolina,  29615,  United States; Recruiting

Texas
      Warner Chilcott Investigational Site, San Antonio,  Texas,  78229,  United States; Recruiting

      Warner Chilcott Investigational Site, Houston,  Texas,  77030,  United States; Recruiting

Utah
      Warner Chilcott Investigational Site, Salt Lake City,  Utah,  84109,  United States; Recruiting

      Warner Chilcott Investigational Site, Magna,  Utah,  84044,  United States; Recruiting

      Warner Chilcott Investigational Site, Salt Lake City,  Utah,  84017,  United States; Recruiting

      Warner Chilcott Investigational Site, Sandy,  Utah,  84070,  United States; Recruiting

Virginia
      Warner Chilcott Investigational Site, Norfolk,  Virginia,  23507-1627,  United States; Recruiting

      Warner Chilcott Investigational Site, Richmond,  Virginia,  23233,  United States; Recruiting

      Warner Chilcott Investigational Site, Virginia Beach,  Virginia,  23456,  United States; Recruiting

Washington
      Warner Chilcott Investigational Site, Spokane,  Washington,  99207,  United States; Recruiting

      Warner Chilcott Investigational Site, Tacoma,  Washington,  98405,  United States; Recruiting

      Warner Chilcott Investigational Site, Seattle,  Washington,  98105,  United States; Recruiting


Study chairs or principal investigators

Herman Ellman, MD,  Study Director,  Sponsor   

More Information

Study ID Numbers:  PR-05806
Last Updated:  January 16, 2007
Record first received:  October 20, 2006
ClinicalTrials.gov Identifier:  NCT00391807
Health Authority: United States: Food and Drug Administration

Emergency Contraception  (National Women's Health Information Center)
Bone Density Appears to Recover After Adolescents Discontinue Injected Contraceptive  (National Institute of Child Health and Human Development)
ClinicalTrials.gov: Contraception  (National Institutes of Health)
Depo-Provera: An Injectable Contraceptive  (American Academy of Family Physicians)
Delaying Your Period through Oral Contraceptives  (Mayo Foundation for Medical Education and Research)
Emergency Contraception: Directory of Providers  (Princeton University, Office of Population Research)
Emergency Contraception  (Nemours Foundation)
Contraception d'Urgence  (Princeton University, Office of Population Research)
Combined Injectable Contraceptives (CICs) FAQ  (Family Health International)
Hormonal Contraception Does Not Appear to Increase HIV Risk  (National Institute of Child Health and Human Development)
Oral Contraceptives and Cancer Risk  (National Cancer Institute)
Birth Control Guide  (Food and Drug Administration)
Birth Control for Women with Epilepsy  (Epilepsy Foundation)
Lactational Amenorrhea FAQ  (Family Health International)
Natural Methods of Family Planning FAQ  (Family Health International)
Teen Talk: What You Should Know about Contraception  (Office of Public Health and Science, Office of Population Affairs) Links to PDF File.
Birth Control Pill FAQ: From Menstruation to Menopause — and Everything in Between  (Mayo Foundation for Medical Education and Research)
FDA's Decision Regarding Plan B: Questions and Answers  (Center for Drug Evaluation and Research)
13-Month Supply of Birth Control Pills Leads to More Consistent Use, Less Expense  (American College of Obstetricians and Gynecologists)
Spermicide  (Nemours Foundation)
Birth Control  (Mayo Foundation for Medical Education and Research)
Natural Family Planning  (American Academy of Family Physicians)
Tubal Sterilization: What You Should Know  (American Academy of Family Physicians)



 



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