Pearl Index Study With Low Dose Combined Oral Contraceptive

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Minisiston (SH D00342A)

• Registration Number: NCT00220324
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

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 Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Study Completion: 2005-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 840

Inclusion Criteria

• Healthy women requiring contraception

Exclusion Criteria

• Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Minisiston (SH D00342A)	-

Primary Outcome Measures

Name	Time	Method
Unadjusted Pearl Index	After 13 cycles of intake

Secondary Outcome Measures

Name	Time	Method
Bleeding pattern	After 13 cycles of intake
Cycle control	After 13 cycles of intake
Adjusted Pearl Index	After 13 cycles of intake
Cumulative pregnancy rate	After 13 cycles of intake