Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: levonorgestrel/ethinyl estradiol (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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 data concerning LNG/EE in
healthy, cycling women.
Clinical Details
Official title: An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study
Primary outcome: Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound
Secondary outcome: Additional safety--clinical labselectrocardiograms (ECGs) vital signs and adverse event recording over 4 days following administration of each formulation (LNG/EE)
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Women 18 - 35 years of age
- Non-smokers
Exclusion Criteria:
- History of thromboembolic disease
- Prior adverse experiences with oral contraceptives
Locations and Contacts
Miami, Florida 33126, United States
Additional Information
Starting date: May 2006
Last updated: February 27, 2007
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