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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
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) ]
  • Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population [ Time Frame: 13 Cycles, 28 days each (1 year) ]

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

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

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

  • Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ]
  • Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ]
  • Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ]
  • Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ]
  • Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ]
  • Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population [ Time Frame: 12 cycles, 28 days each (336 days) ]
  • Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ]
  • Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ]
  • Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ]
  • Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ]
  • Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ]
  • Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ]

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   (Adult)
Sexes 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

  Show 66 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Sponsor GmbH
  More Information

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

Keywords provided by Warner Chilcott:
Contraception

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

ClinicalTrials.gov processed this record on February 24, 2017