Bleeding Pattern Study

Tracking Information
First Submitted Date ICMJE	February 23, 2006
First Posted Date ICMJE	March 14, 2006
Last Update Posted Date	May 18, 2009
Study Start Date ICMJE	June 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: March 13, 2006)	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; (submitted: March 13, 2006)	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: None (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
Actual Enrollment ICMJE; (submitted: May 15, 2009)	1315
Original Enrollment ICMJE	Not Provided
Actual Study 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