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