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

NCT00319163 ↗

Phase 1 Completed 26 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

Non-randomizedCrossoverOpen-labelPrevention

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.

Timeline

Start: 2006-05
Primary completion: 2006-11
Completion: 2006-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	90 mg	—
Subject	ethinyl estradiol	Small molecule	20 mg	—

Indications

No indication recorded.