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

Tracking Information

First Received Date ^ICMJE

March 13, 2007

Last Updated Date

July 14, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00447863 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

Condition ^ICMJE

Contraception

Intervention ^ICMJE

Drug: Levonorgestrel/Ethinyl Estradiol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00447863

Responsible Party

Study ID Numbers ^ICMJE

0858A2-109

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP