Efficacy and Safety of Two Extended Regimens (Yaz Flex) in Comparison With the Conventional Regimen of YAZ - Tabular View

Tracking Information

First Received Date ^ICMJE

December 3, 2007

Last Updated Date

October 9, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary efficacy variable is the number of observed unintended pregnancies during 1 year of treatment. [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy variable is the number of observed unintended pregnancies during 1 year of treatment. [ Time Frame: Approximately 1 year ]

Change History

Complete list of historical versions of study NCT00567164 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The secondary efficacy parameters include bleeding parameters and menstrual related symptoms. [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The secondary efficacy parameters include bleeding parameters and menstrual related symptoms. [ Time Frame: Approximately 1 year ]

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Two Extended Regimens (Yaz Flex) in Comparison With the Conventional Regimen of YAZ

Official Title ^ICMJE

A Multicenter, Open-label, Three-arm, Active-controlled Study to Assess the Efficacy and Safety of the Oral Contraceptive SH T00186D in Two Flexible Extended Regimens and a Conventional Regimen of Yaz in 1756 Healthy Females for 1 Year

Brief Summary

The purpose of this study is to determine whether the study drug is safe and effective

Detailed Description

The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Oral Contraception
Healthy

Intervention ^ICMJE

Drug: Yaz (SH T00186D)
Drug: SH T00186D
Drug: SH T00189D, SH T470PD

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

Active, not recruiting

Estimated Enrollment ^ICMJE

1756

Estimated Completion Date

November 2009

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.

Exclusion Criteria:

The use of steroidal oral contraceptives , or any drug that could alter Oral contraception metabolism will be prohibited during the study.

Gender

Female

Ages

18 Years to 45 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

NCT00567164

Responsible Party

Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.

Study ID Numbers ^ICMJE

91698, 311642

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

October 2009

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