Study of Safety and Efficacy of an Oral Contraceptive

Overview

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.

Full Title of Study: “Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2008

Interventions

  • Drug: Norethindrone acetate/ethinyl estradiol
    • one tablet per day

Arms, Groups and Cohorts

  • Experimental: study drug
    • Norethindrone/Ethinyl Estradiol

Clinical Trial Outcome Measures

Primary 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 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)

Participating in This Clinical Trial

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
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: 45 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Warner Chilcott
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Herman Ellman, MD, Study Director, Sponsor GmbH

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.