Status:
COMPLETED
Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy
Eligibility:
FEMALE
18-35 years
Phase:
PHASE1
Brief Summary
Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE. Secondary Objective: To obtain additional safety and tolerability...
Eligibility Criteria
Inclusion
- Women 18 - 35 years of age
- Non-smokers
Exclusion
- History of thromboembolic disease
- Prior adverse experiences with oral contraceptives
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00319163
Start Date
May 1 2006
End Date
November 1 2006
Last Update
August 7 2009
Active Locations (1)
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1
Miami, Florida, United States, 33126