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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01200186
First received: August 13, 2010
Last updated: August 19, 2014
Last verified: August 2014

August 13, 2010
August 19, 2014
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Time to event for discontinuation due to reasons other than bleeding irregularities [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
  • Number of intracyclic bleeding [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
  • Number of intracyclic bleeding [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
  • Number of heavy and/or prolonged bleeding [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
  • Number of heavy and/or prolonged bleeding [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
  • Number of unintended pregnancies [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
  • Number of unintended pregnancies [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Global assessment of well-being and satisfaction [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
  • Global assessment of well-being and satisfaction [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
  • Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy [ Time Frame: up to 12 Months ] [ Designated as safety issue: Yes ]
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.
 
Active, not recruiting
3000
September 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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   France,   Germany,   Greece,   United Kingdom,   Israel,   Italy,   Russian Federation,   Slovakia,   Sweden,   Czech Republic
 
NCT01200186
15217, QL0901
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
August 2014

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