Study of Bleeding With Extended Administration of an Oral Contraceptive

Overview

This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.

Full Title of Study: “Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2007

Interventions

  • Drug: Norethindrone 1 mg / ethinyl estradiol 20 mcg

Clinical Trial Outcome Measures

Primary Measures

  • Number of bleeding/spotting days/episodes per treatment cycle

Secondary Measures

  • Satisfaction

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy women – Age 25-40 – History of regular cycles Exclusion Criteria:

  • Current or recent (within 2 months) users of hormonal contraceptives – Contraindications for use of hormonal contraception – Conditions which affect the absorption or metabolism of steroid hormones – BMI > 35

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

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

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