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

Tracking Information

First Received Date ^ICMJE

April 26, 2006

Last Updated Date

August 5, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00319163 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Additional safety--clinical labs
electrocardiograms (ECGs)
vital signs
and adverse event recording over 4 days following administration of each formulation (LNG/EE)

Original Secondary Outcome Measures ^ICMJE

additional safety--clinical labs, ECGS, vital signs, and adverse event recording over 4 days following administration of each formulation (LNG/EE)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study

Condition ^ICMJE

Healthy

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

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women 18 - 35 years of age
Non-smokers

Exclusion Criteria:

History of thromboembolic disease
Prior adverse experiences with oral contraceptives

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

NCT00319163

Responsible Party

Study ID Numbers ^ICMJE

0858A2-108

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

August 2009

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