Efficacy and Safety Oral Contraceptive Study
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: YAZ (ethinyl estradiol drospirenone, SH T 186 D) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
The purpose of this study is to determine whether the study drug is effective in prevention
of pregnancy in healthy women in reproductive age
Clinical Details
Official title: Multi-Center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-Cyclodextrin Clathrate and 3 mg Drospirenone in a 24-Day Regimen for 13 Cycles in 1010 Healthy Female Volunteers
Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Rate of unintended pregnancies (Pearl index)
Secondary outcome: Physical and gynecological examinationVital signs Body weight Cervical smear
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy woman requesting contraception
- Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)
Exclusion Criteria:
- Any conditions might interfere study outcome
Locations and Contacts
Additional Information
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Starting date: March 2004
Ending date: January 2006
Last updated: April 29, 2008
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