Bleeding Pattern Study

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00302666

First received: February 23, 2006

Last updated: May 15, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Bleeding pattern

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00302666 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety, contraceptive efficacy

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bleeding Pattern Study

Official Title ^ICMJE

Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers

Brief Summary

The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Oral Contraceptive

Intervention ^ICMJE

Drug: Valette (Dienogest/EE30, BAY86-5038)
Oral contraceptive extended cycles
Drug: Valette (Dienogest/EE30, BAY86-5038)
Oral contraceptive conventional cycles

Study Arms

Sham Comparator: Arm 1
Intervention: Drug: Valette (Dienogest/EE30, BAY86-5038)
Sham Comparator: Arm 2
Intervention: Drug: Valette (Dienogest/EE30, BAY86-5038)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1315

Completion Date

February 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy female volunteers aged between 18 and 40 years requiring contraception.

Exclusion Criteria:

Pregnancy or lactation.
Any conditions that might interfere with the outcome as well as all contraindications for OC use.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years to 40 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00302666

Other Study ID Numbers ^ICMJE

91227
306903

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Therapeutic Area Head, Bayer Schering Pharma AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

PRS Account

Bayer

Verification Date

May 2009

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

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