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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00266032
Recruitment Status : Completed
First Posted : December 15, 2005
Results First Posted : March 3, 2010
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE December 14, 2005
First Posted Date  ICMJE December 15, 2005
Results First Submitted Date  ICMJE October 28, 2009
Results First Posted Date  ICMJE March 3, 2010
Last Update Posted Date November 3, 2014
Study Start Date  ICMJE December 2005
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
  • Number of Days With Bleeding Including Spotting [ Time Frame: up to 1 year ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2005)
Number of days with bleeding/spotting
Change History Complete list of historical versions of study NCT00266032 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
  • Number of Days With Bleeding Excluding Spotting [ Time Frame: up to 1 year ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2005)
  • Parameters of safety and tolerability
  • Number of unintended pregnancies
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
Official Title  ICMJE A Multicenter, Open, Randomized, Parallel Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Variations of an Extended Regimen vs. a Standard Regimen (24 + 4 Days) in 1122 Healthy Female Volunteers for One Year, Followed by a One Year Safety Extension
Brief Summary The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • Drug: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)
    3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
  • Drug: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)
    3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
  • Drug: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
    13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
Study Arms  ICMJE
  • Experimental: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)
    3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
    Intervention: Drug: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)
  • Experimental: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)
    3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
    Intervention: Drug: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)
  • Active Comparator: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
    13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
    Intervention: Drug: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2010)
1166
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy women who desire contraception
  • smokers ≤ 30 Years old

Exclusion Criteria:

  • Contraindication against use of hormonal contraceptives
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00266032
Other Study ID Numbers  ICMJE 91450
2005-002125-32 ( EudraCT Number )
308683 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP