Study of Bleeding With Extended Administration of an Oral Contraceptive
Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets
1 other identifier
interventional
207
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2006
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 16, 2006
CompletedFirst Posted
Study publicly available on registry
June 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMay 8, 2008
May 1, 2008
11 months
June 16, 2006
May 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of bleeding/spotting days/episodes per treatment cycle
Secondary Outcomes (1)
Satisfaction
Interventions
Eligibility Criteria
You may qualify if:
- Healthy women
- Age 25-40
- History of regular cycles
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (23)
Warner Chilcott Investigational Site
Phoenix, Arizona, 85031, United States
Warner Chilcott Investigational Site
Phoenix, Arizona, 85050, United States
Warner Chilcott Investigational Site
Tempe, Arizona, 85283, United States
Warner Chilcott Investigational Site
Carmichael, California, 95608, United States
Warner Chilcott Investigational Site
Boynton Beach, Florida, 33437, United States
Warner Chilcott Investigational Site
Leesburg, Florida, 34748, United States
Warner Chilcott Investigational Site
Miami, Florida, 33143, United States
Warner Chilcott Investigational Site
Miami, Florida, 33186, United States
Warner Chilcott Investigational Site
West Palm Beach, Florida, 33401, United States
Warner Chilcott Investigational Site
Decatur, Georgia, 30034, United States
Warner Chilcott Investigational Site
Roswell, Georgia, 30075, United States
Warner Chilcott Investigational Site
Peoria, Illinois, 61615, United States
Warner Chilcott Investigational Site
Lexington, Kentucky, 40509, United States
Warner Chilcott Investigational Site
Louisville, Kentucky, 40291, United States
Warner Chilcott Investigational Site
New Bern, North Carolina, 28562, United States
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, 27103, United States
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, 19114, United States
Warner Chilcott Investigational Site
Greenville, South Carolina, 29607, United States
Warner Chilcott Investigational Site
Pleasant Grove, Utah, 84062, United States
Warner Chilcott Investigational Site
Salt Lake City, Utah, 84017, United States
Warner Chilcott Investigational Site
Sandy City, Utah, 84070, United States
Warner Chilcott Investigational Site
Virginia Beach, Virginia, 23456, United States
Warner Chilcott Investigational Site
Seattle, Washington, 98105, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Herman Ellman, MD
Sponsor GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2006
First Posted
June 20, 2006
Study Start
June 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
May 8, 2008
Record last verified: 2008-05