Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women

This study has been withdrawn prior to enrollment.

First Received: March 13, 2007 Last Updated: July 14, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00447863

Purpose

Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.

Condition	Intervention	Phase
Contraception	Drug: Levonorgestrel/Ethinyl Estradiol	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg in 2 Dosage Forms With Different Dissolution Characteristics in Healthy, Cycling Women

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

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:

To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics

Secondary Outcome Measures:

To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women

Study Start Date:	August 2007
Estimated Study Completion Date:	August 2007

Eligibility

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

Criteria

Inclusion Criteria:

Women aged 18 to 35 years.
Healthy as determined by the investigator on the basis of medical history and screening evaluations.
Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.

Exclusion Criteria:

Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447863

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:	0858A2-109
Study First Received:	March 13, 2007
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00447863 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Estradiol 17 beta-cypionate
Hormones
Estradiol
Pharmacologic Actions
Therapeutic Uses
Estradiol 3-benzoate
Levonorgestrel
Contraceptives, Oral, Synthetic
Polyestradiol phosphate

ClinicalTrials.gov processed this record on March 18, 2010