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Completed

NCT Number: NCT00391807

Study of Safety and Efficacy of an Oral Contraceptive

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.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Warner Chilcott Investigational Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norethindrone acetate/ethinyl estradiol

Drug

one tablet per day

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 24, 2006
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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