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: April 26, 2006 Last Updated: August 5, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
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:	Prevention, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study
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:

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

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

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

Keywords provided by Wyeth:

oral contraceptive
therapeutic equivalency
contraceptives, oral, combined

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Estradiol 17 beta-cypionate
Reproductive Control Agents

Hormones
Pharmacologic Actions
Estradiol
Contraceptives, Oral, Combined
Therapeutic Uses
Estradiol 3-benzoate
Levonorgestrel
Contraceptives, Oral, Synthetic
Polyestradiol phosphate

ClinicalTrials.gov processed this record on November 09, 2009