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

This study has been completed.

First Received on April 26, 2006. Last Updated on August 5, 2009 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00319163

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 I

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:

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate

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 February 12, 2012