Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00319163

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

26

Starts

2006-05-01

Expected to finish

2006-11-01

Last updated by the study team

2009-08-07

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women 18 - 35 years of age
• Non-smokers

You may not qualify if…

• History of thromboembolic disease
• Prior adverse experiences with oral contraceptives

Where it is running

• Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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