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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)

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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