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”

The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age

Study Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
  • Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1

Primary Measures

• Rate of unintended pregnancies (Pearl index)
  • Time Frame: 13 cycles of 28 days
    

Secondary Measures

• Physical and gynecological examination
  • Time Frame: screening, cycle 6 and final examination
    
• Vital signs
  • Time Frame: each visit
    
• Body weight
  • Time Frame: each visit
    
• Cervical smear
  • Time Frame: each visit
    

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185484

Study ID Number: 91353

ClinicalTrials.gov Identifier: NCT00185484

Health Authority: Hungary: National Institute of Pharmacy

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