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Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200186
First Posted: September 13, 2010
Last Update Posted: October 16, 2015
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.
Information provided by (Responsible Party):
Bayer
August 13, 2010
September 13, 2010
October 16, 2015
October 2010
February 2014   (Final data collection date for primary outcome measure)
The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities. [ Time Frame: up to 12 Months ]
Same as current
Complete list of historical versions of study NCT01200186 on ClinicalTrials.gov Archive Site
  • Time to event for discontinuation due to reasons other than bleeding irregularities [ Time Frame: Month 3-5 ]
  • Time to event for discontinuation due to reasons other than bleeding irregularities [ Time Frame: Month 6-12 ]
  • Number of intracyclic bleeding [ Time Frame: Month 3-5 ]
  • Number of intracyclic bleeding [ Time Frame: Month 6-12 ]
  • Number of heavy and/or prolonged bleeding [ Time Frame: Month 3-5 ]
  • Number of heavy and/or prolonged bleeding [ Time Frame: Month 6-12 ]
  • Number of unintended pregnancies [ Time Frame: Month 3-5 ]
  • Number of unintended pregnancies [ Time Frame: Month 6-12 ]
  • Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons [ Time Frame: Month 3-5 ]
  • Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons [ Time Frame: Month 6-12 ]
  • Global assessment of well-being and satisfaction [ Time Frame: Month 3-5 ]
  • Global assessment of well-being and satisfaction [ Time Frame: Month 6-12 ]
  • Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy [ Time Frame: up to 12 Months ]
Same as current
Not Provided
Not Provided
 
Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Women in gynecological practice
Contraceptives, Oral
  • Drug: EV/DNG (Qlaira, BAY86-5027)
    At the discretion of the attending physician
  • Drug: Progestin Only Pills
    At the discretion of the attending physician
  • Group 1
    Intervention: Drug: EV/DNG (Qlaira, BAY86-5027)
  • Group 2
    Intervention: Drug: Progestin Only Pills
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3258
October 2014
February 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women between 18-50 years
  • Women who used ethinylestradiol containing oral contraceptives for at least the three preceding months before the study
  • Women who decided to start Qlaira® or a Progestin Only Pill. The prescription of the hormonal contraceptive is made at the discretion of the attending physician and has to be documented

Exclusion Criteria:

  • Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
  • Women who are breast-feeding
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Russian Federation,   Slovakia,   Sweden,   United Kingdom
Austria,   Norway
 
NCT01200186
15217
QL0901 ( Other Identifier: Company Internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2015
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