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

Phase 1CompletedNCT00319163

Wyeth is now a wholly owned subsidiary of Pfizer26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

levonorgestrel/ethinyl estradiolDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women 18 - 35 years of age * Non-smokers Exclusion Criteria: * History of thromboembolic disease * Prior adverse experiences with oral contraceptives

Locations (1)

Unnamed facility

Miami, Florida, United States

Outcomes

Primary Outcomes

Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound

Secondary Outcomes

Additional safety--clinical labs

electrocardiograms (ECGs)

vital signs

and adverse event recording over 4 days following administration of each formulation (LNG/EE)

Data from ClinicalTrials.gov

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