Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles

• Number of Days With Bleeding Including Spotting [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.
  
  
• Number of Unintended Pregnancies in Yaz Flexible Arm [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.
  
  
• Pearl Index [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.
  
  
• Number of Unintended Pregnancies Due to Method Failure [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.
  
  
• Adjusted Pearl Index [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.
  
  

• Number of Days With Bleeding Excluding Spotting [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity light, normal, or heavy.
  
  
• Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  For early dropouts and pregnant subjects with an exposure period of less than 1 year but at least 248 days, the number of bleeding/spotting days was normalized to correspond to a 1-year exposure period.
  
  
• Number of Bleeding / Spotting Days by 90-day Reference Period [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  The mean number of bleeding / spotting days, spotting-only and bleeding days was analyzed using reference periods of 90 days as recommended by the WHO.
  
  
• Number of Bleeding / Spotting Episodes in 90 Day Reference Period [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  The mean number of bleeding / spotting episodes was analyzed using reference periods of 90 days as recommended by the WHO.
  
  
• Days With Scheduled Versus Unscheduled Bleeding [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  Days with scheduled and unscheduled bleeding were evaluated for extended regimens only. Unscheduled is any bleeding/spotting that occurred while taking active hormones regardless of the duration of intake, unless they occurred after tablet-free interval during days 1-4 of subsequent treatment cycle, or unless they occurred during days 1-7 of first treatment cycle. Scheduled is any bleeding/spotting that occurred during tablet-free interval, regardless of duration of tablet intake, or during next 4 days of subsequent treatment cycle.
  
  

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG (BSP AG), Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed from result posting as it is covered by the Adverse Event section.