Study of Safety and Efficacy of an Oral Contraceptive

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00391807
First received: October 20, 2006
Last updated: April 15, 2013
Last verified: April 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]
  • Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population [ Time Frame: 13 Cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population [ Time Frame: 2 Cycles, 28 days each (56 days) ] [ Designated as safety issue: Yes ]
    MITT Population

  • Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: Yes ]
    MITT Population

  • Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: Yes ]
    MITT Population

  • Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]
  • Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ] [ Designated as safety issue: No ]
  • Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: No ]
  • Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population [ Time Frame: 12 cycles, 28 days each (336 days) ] [ Designated as safety issue: No ]
  • Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ] [ Designated as safety issue: No ]
  • Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: No ]
  • Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]

Enrollment: 1683
Study Start Date: November 2006
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: study drug
Norethindrone/Ethinyl Estradiol
Drug: Norethindrone acetate/ethinyl estradiol
one tablet per day

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391807

  Hide Study Locations
Locations
United States, Arizona
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85014
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85050
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85015
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85032
Warner Chilcott Investigational Site
Tempe, Arizona, United States
Warner Chilcott Investigational Site
Tempe, Arizona, United States, 85283
Warner Chilcott Investigational Site
Tucson, Arizona, United States, 85712
United States, California
Warner Chilcott Investigational Site
Carmichael, California, United States, 95608
Warner Chilcott Investigational Site
San Diego, California, United States, 92108
Warner Chilcott Investigational Site
San Diego, California, United States, 92103
United States, Colorado
Warner Chilcott Investigational Site
Denver, Colorado, United States, 80218
United States, Florida
Warner Chilcott Investigational Site
Boynton Beach, Florida, United States, 33437
Warner Chilcott Investigational Site
Clearwater, Florida, United States, 33759
Warner Chilcott Investigational Site
Jacksonville, Florida, United States, 32207
Warner Chilcott Investigational Site
Leesburg, Florida, United States, 34748
Warner Chilcott Investigational Site
Longwood, Florida, United States, 32779
Warner Chilcott Investigational Site
Miami, Florida, United States, 33143
Warner Chilcott Investigational Site
Miami, Florida, United States, 33186
Warner Chilcott Investigational Site
New Port Richey, Florida, United States, 34652
Warner Chilcott Investigational Site
Pembroke Pines, Florida, United States
Warner Chilcott Investigational Site
Plantation, Florida, United States, 33324
Warner Chilcott Investigational Site
St. Petersburg, Florida, United States, 33709
Warner Chilcott Investigational Site
West Palm Beach, Florida, United States, 33401
Warner Chilcott Investigational Site
West Palm Beach, Florida, United States
United States, Georgia
Warner Chilcott Investigational Site
Roswell, Georgia, United States, 30075
Warner Chilcott Investigational Site
Sandy Springs, Georgia, United States, 30328
United States, Illinois
Warner Chilcott Investigational Site
Champaign, Illinois, United States, 61820
Warner Chilcott Investigational Site
Peoria, Illinois, United States, 61615
United States, Indiana
Warner Chilcott Investigational Site
Indianapolis, Indiana, United States
United States, Kansas
Warner Chilcott Investigational Site
Wichita, Kansas, United States
United States, Kentucky
Warner Chilcott Investigational Site
Lexington, Kentucky, United States, 40509
Warner Chilcott Investigational Site
Louisville, Kentucky, United States, 40202
Warner Chilcott Investigational Site
Louisville, Kentucky, United States, 40291
United States, New Jersey
Warner Chilcott Investigational Site
Berlin, New Jersey, United States, 08009
Warner Chilcott Investigational Site
Lawrenceville, New Jersey, United States, 08648
Warner Chilcott Investigational Site
Moorestown, New Jersey, United States, 08057
United States, New Mexico
Warner Chilcott Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Warner Chilcott Investigational Site
Cary, North Carolina, United States
Warner Chilcott Investigational Site
New Bern, North Carolina, United States, 28562
Warner Chilcott Investigational Site
Raleigh, North Carolina, United States, 27609
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, United States, 27103
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, United States
United States, Ohio
Warner Chilcott Investigational Site
Cleveland, Ohio, United States, 44122
Warner Chilcott Investigational Site
Columbus, Ohio, United States, 43213
United States, Oklahoma
Warner Chilcott Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Warner Chilcott Investigational Site
Portland, Oregon, United States, 97239
Warner Chilcott Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Warner Chilcott Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
Warner Chilcott Investigational Site
Pottstown, Pennsylvania, United States, 19464-3224
United States, South Carolina
Warner Chilcott Investigational Site
Charleston, South Carolina, United States, 29401
Warner Chilcott Investigational Site
Columbia, South Carolina, United States, 29201
Warner Chilcott Investigational Site
Greenville, South Carolina, United States, 29615
United States, Texas
Warner Chilcott Investigational Site
Dallas, Texas, United States
Warner Chilcott Investigational Site
Houston, Texas, United States, 77030
Warner Chilcott Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Warner Chilcott Investigational Site
Magna, Utah, United States, 84044
Warner Chilcott Investigational Site
Salt Lake City, Utah, United States, 84109
Warner Chilcott Investigational Site
Salt Lake City, Utah, United States, 84017
Warner Chilcott Investigational Site
Sandy, Utah, United States, 84070
United States, Virginia
Warner Chilcott Investigational Site
Norfolk, Virginia, United States, 23507-1627
Warner Chilcott Investigational Site
Richmond, Virginia, United States, 23233
Warner Chilcott Investigational Site
Virginia Beach, Virginia, United States, 23456
United States, Washington
Warner Chilcott Investigational Site
Seattle, Washington, United States, 98105
Warner Chilcott Investigational Site
Spokane, Washington, United States, 99207
Warner Chilcott Investigational Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Sponsor GmbH
  More Information

No publications provided by Warner Chilcott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00391807     History of Changes
Other Study ID Numbers: PR-05806
Study First Received: October 20, 2006
Results First Received: November 23, 2010
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Contraception

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

ClinicalTrials.gov processed this record on August 01, 2014