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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: levonorgestrel/ethinyl estradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00319163

0858A2-108

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)