Study of Bleeding With Extended Administration of an Oral Contraceptive

Phase 2

Completed

• Conditions: Contraception

• Registration Number: NCT00338052
• Lead Sponsor: Warner Chilcott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-16
• Study First Submitted QC: 2006-06-16
• Study First Posted: 2006-06-20
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-07
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 207

Inclusion Criteria

• Healthy women
• Age 25-40
• History of regular cycles

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of bleeding/spotting days/episodes per treatment cycle

Secondary Outcome Measures

Name	Time	Method
Satisfaction

Trial Locations

Locations (1)

Warner Chilcott Investigational Site; 🇺🇸 Seattle, Washington, United States