Pearl Index Study With Low Dose Combined Oral Contraceptive

Contraception Clinical Trial

Official title:

Prospective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to Healthy Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220324
• Other study ID #: 91313
• Secondary ID: 307987
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: April 2, 2015
• Start date: February 2004
• Est. completion date: November 2005

Study information

• Verified date: April 2015
• 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 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.

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: 840
• Est. completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Minisiston (SH D00342A)
Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval

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	Unadjusted Pearl Index		After 13 cycles of intake	No
Secondary	Adjusted Pearl Index		After 13 cycles of intake	No
Secondary	Cumulative pregnancy rate		After 13 cycles of intake	No
Secondary	Bleeding pattern		After 13 cycles of intake	No
Secondary	Cycle control		After 13 cycles of intake	No

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