Overview

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

Status:
Completed

Trial end date:
2006-11-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Treatments:

Contraceptives, Oral, Combined
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Levonorgestrel
Polyestradiol phosphate