Official Title: “A Multicenter, Open, Randomized, Parallel-Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T 00186 D in Extended Cycles vs. a Standard Regimen in Healthy Female Volunteers for up to Two Years”

The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel 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 (SH T00186 DF)
  • EE and DRSP, 24-day period with daily intake of 1 active tablet, followed by a 4-day period with daily intake of 1 inactive tablet (placebo)
• Drug: YAZ extended (SH T 04210 A)
  • Ethinylestradiol (EE) and drospirenone (DRSP), daily intake of 1 tablet for an intended period of 120 days, followed by a 4-day tablet-free interval.Minimal period of tablet intake between two tablet-free intervals is 24 days. After each 4-day tablet-free interval a new intended 120-day period will start again
• Drug: YAZ extended (SH T 04210 A)
  • EE and DRSP, 120-day period with consecutive daily intake of 1 tablet followed by a 4-day tablet-free interval over a total of 3 periods

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a
• Experimental: Arm 2
  • n/a
• Placebo Comparator: Arm 3
  • n/a

Primary Measures

• Number of days with bleeding/spotting
  • Time Frame: Approximately 1 year, followed by a 1-year safety extension
    Safety Issue?: No
• Number of unintended pregnancies (Pearl Index, life table analysis)
  • Time Frame: Approximately 1 year, followed by a 1-year safety extension
    Safety Issue?: No

Secondary Measures

• Parameters of safety and tolerability
  • Time Frame: Approximately 1 year, followed by a 1-year safety extension
    Safety Issue?: Yes

Inclusion Criteria:

• Healthy women who desire contraception

Exclusion Criteria:

• Contraindication against use of hormonal contraceptives

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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00266032

Study ID Number: 91450

ClinicalTrials.gov Identifier: NCT00266032

Health Authority: Canada: Health Canada

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product

Click here to find results for studies related to marketed products