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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00319163
First received: April 26, 2006
Last updated: August 5, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: levonorgestrel/ethinyl estradiol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-label, Single-dose, Randomized, 2-period, Crossover, Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound

Secondary Outcome Measures:
  • Additional safety--clinical labs
  • electrocardiograms (ECGs)
  • vital signs
  • and adverse event recording over 4 days following administration of each formulation (LNG/EE)

Estimated Enrollment: 26
Study Start Date: May 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of thromboembolic disease
  • Prior adverse experiences with oral contraceptives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319163

Locations
United States, Florida
Miami, Florida, United States, 33126
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319163     History of Changes
Other Study ID Numbers: 0858A2-108
Study First Received: April 26, 2006
Last Updated: August 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
oral contraceptive
therapeutic equivalency
contraceptives, oral, combined

Additional relevant MeSH terms:
Contraceptives, Oral
Levonorgestrel
Contraceptives, Oral, Combined
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents, Female
 Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on May 22, 2013