Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00319163
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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 data concerning LNG/EE in healthy, cycling women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 26
Inclusion Criteria
- Women 18 - 35 years of age
- Non-smokers
Exclusion Criteria
- History of thromboembolic disease
- Prior adverse experiences with oral contraceptives
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound
- Secondary Outcome Measures
Name Time Method Additional safety--clinical labs electrocardiograms (ECGs) vital signs and adverse event recording over 4 days following administration of each formulation (LNG/EE)