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

This study is not yet open for participant recruitment.

Verified by Wyeth, June 2007

Sponsored by:	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

MedlinePlus related topics: Birth Control

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
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

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

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, Florida

Miami, Florida, United States, 33126

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0858A2-109
Study First Received:	March 13, 2007
Last Updated:	June 19, 2007
ClinicalTrials.gov Identifier:	NCT00447863
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Benzoates
Levonorgestrel
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol

Estradiol 17 beta-cypionate
Healthy
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female

Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009