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Study of Safety and Efficacy of an Oral Contraceptive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00391807
Recruitment Status : Completed
First Posted : October 24, 2006
Results First Posted : December 22, 2010
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Drug: Norethindrone acetate/ethinyl estradiol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1683 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
Experimental: study drug
Norethindrone/Ethinyl Estradiol
 Drug: Norethindrone acetate/ethinyl estradiol
one tablet per day


Outcome Measures
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Primary Outcome Measures :
  1. Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, [ Time Frame: 13 cycles, 28 days each (1 year) ]
  2. 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 :
  1. Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population [ Time Frame: 2 Cycles, 28 days each (56 days) ]
    MITT Population

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

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

  4. Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ]
  5. Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ]
  6. Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ]
  7. Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ]
  8. Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ]
  9. Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population [ Time Frame: 12 cycles, 28 days each (336 days) ]
  10. Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ]
  11. Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ]
  12. Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ]
  13. Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ]
  14. Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ]
  15. Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391807


Locations
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Sponsors and Collaborators
Warner Chilcott
Investigators
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Study Director: Herman Ellman, MD Sponsor GmbH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00391807    
Other Study ID Numbers: PR-05806
First Posted: October 24, 2006    Key Record Dates
Results First Posted: December 22, 2010
Last Update Posted: April 22, 2013
Last Verified: April 2013
Keywords provided by Warner Chilcott:
Contraception
Additional relevant MeSH terms:
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Ethinyl Estradiol
Norethindrone
Norethindrone Acetate
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptives, Oral, Synthetic