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

NCT00319163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2009-08-07

No results posted yet for this study

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

DRUG

levonorgestrel/ethinyl estradiol

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319163 on ClinicalTrials.gov