check_circleStudy Completed

Contraceptives, Oral

Bayer Identifier:

15217

ClinicalTrials.gov Identifier:

NCT01200186

EudraCT Number:

Not Available

EU CT Number:

Not Available
Non-interventional study on oral contraception not containing ethinylestradiol (EE) to assess continuation rates and satisfaction

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years
  • - 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

  • - Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
    - Women who are breast-feeding

Trial summary

Enrollment Goal
3258
Trial Dates
October 2010 - October 2014
Phase
Phase 4
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France
Withdrawn
Many Locations, Austria
Completed
Many Locations, United Kingdom
Completed
Many Locations, Sweden
Withdrawn
Many Locations, Norway
Completed
Many Locations, Hungary
Completed
Many Locations, Greece
Completed
Many Locations, Slovakia
Completed
Many Locations, Germany
Completed
Many Locations, Italy
Completed
Many Locations, Czech Republic
Completed
Many locations, Israel
Completed
Many Locations, Russia

Primary Outcome

  • The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.
    date_rangeTime Frame:
    up to 12 Months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time to event for discontinuation due to reasons other than bleeding irregularities
    date_rangeTime Frame:
    Month 3-5
    enhanced_encryption
    Safety Issue:
    No
  • Time to event for discontinuation due to reasons other than bleeding irregularities
    date_rangeTime Frame:
    Month 6-12
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    Safety Issue:
    No
  • Number of intracyclic bleeding
    date_rangeTime Frame:
    Month 3-5
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    Safety Issue:
    No
  • Number of intracyclic bleeding
    date_rangeTime Frame:
    Month 6-12
    enhanced_encryption
    Safety Issue:
    No
  • Number of heavy and/or prolonged bleeding
    date_rangeTime Frame:
    Month 3-5
    enhanced_encryption
    Safety Issue:
    No
  • Number of heavy and/or prolonged bleeding
    date_rangeTime Frame:
    Month 6-12
    enhanced_encryption
    Safety Issue:
    No
  • Number of unintended pregnancies
    date_rangeTime Frame:
    Month 3-5
    enhanced_encryption
    Safety Issue:
    No
  • Number of unintended pregnancies
    date_rangeTime Frame:
    Month 6-12
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    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
    date_rangeTime Frame:
    Month 3-5
    enhanced_encryption
    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
    date_rangeTime Frame:
    Month 6-12
    enhanced_encryption
    Safety Issue:
    No
  • Global assessment of well-being and satisfaction
    date_rangeTime Frame:
    Month 3-5
    enhanced_encryption
    Safety Issue:
    No
  • Global assessment of well-being and satisfaction
    date_rangeTime Frame:
    Month 6-12
    enhanced_encryption
    Safety Issue:
    No
  • Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy
    date_rangeTime Frame:
    up to 12 Months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Non-interventional study on oral contraception not containing ethinylestradiol (EE) to assess continuation rates and satisfaction
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
Non-randomized
Blinding
N/A
Assignment
N/A
Trial Arms
2

Additional Information

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