NCT00319163

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (planned)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	levonorgestrel/ethinyl estradiol

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2006-04-27
• Last updated: 2009-08-07

Locations

1 site across 1 country: United States