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NCT00338052 Clinical Trial

Study of Bleeding With Extended Administration of an Oral Contraceptive

Contraception Clinical Trial

Official title:
Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00338052
Other study ID # PR-02306
Secondary ID
Status Completed
Phase Phase 2
First received June 16, 2006
Last updated May 7, 2008
Start date June 2006
Est. completion date May 2007

Study information
Verified date May 2008
Source Warner Chilcott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 207
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 40 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Norethindrone 1 mg / ethinyl estradiol 20 mcg

Locations
Country Name City State
United States Warner Chilcott Investigational Site Boynton Beach Florida
United States Warner Chilcott Investigational Site Carmichael California
United States Warner Chilcott Investigational Site Decatur Georgia
United States Warner Chilcott Investigational Site Greenville South Carolina
United States Warner Chilcott Investigational Site Leesburg Florida
United States Warner Chilcott Investigational Site Lexington Kentucky
United States Warner Chilcott Investigational Site Louisville Kentucky
United States Warner Chilcott Investigational Site Miami Florida
United States Warner Chilcott Investigational Site Miami Florida
United States Warner Chilcott Investigational Site New Bern North Carolina
United States Warner Chilcott Investigational Site Peoria Illinois
United States Warner Chilcott Investigational Site Philadelphia Pennsylvania
United States Warner Chilcott Investigational Site Phoenix Arizona
United States Warner Chilcott Investigational Site Phoenix Arizona
United States Warner Chilcott Investigational Site Pleasant Grove Utah
United States Warner Chilcott Investigational Site Roswell Georgia
United States Warner Chilcott Investigational Site Salt Lake City Utah
United States Warner Chilcott Investigational Site Sandy Utah
United States Warner Chilcott Investigational Site Seattle Washington
United States Warner Chilcott Investigational Site Tempe Arizona
United States Warner Chilcott Investigational Site Virginia Beach Virginia
United States Warner Chilcott Investigational Site West Palm Beach Florida
United States Warner Chilcott Investigational Site Winston Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of bleeding/spotting days/episodes per treatment cycle
Secondary Satisfaction
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