Bleeding Pattern Study

Oral Contraceptive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302666
• Other study ID #: 91227
• Secondary ID: 306903
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2006
• Last updated: May 15, 2009
• Start date: June 2003
• Est. completion date: February 2005

Study information

• Verified date: May 2009
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1315
• Est. completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Oral Contraceptive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding pattern
Secondary	Safety, contraceptive efficacy

External Links

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