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: May 21, 2014
Last verified: May 2014
  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.


Condition Intervention Phase
Contraceptives, Oral
Drug: EV/DNG (Qlaira, BAY86-5027)
Drug: Progestin Only Pills
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: October 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: EV/DNG (Qlaira, BAY86-5027)
At the discretion of the attending physician
Group 2 Drug: Progestin Only Pills
At the discretion of the attending physician

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women in gynecological practice

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200186

Locations
Czech Republic
Many Locations, Czech Republic
France
Many Locations, France
Germany
Many Locations, Germany
Greece
Many Locations, Greece
Hungary
Many Locations, Hungary
Israel
Many locations, Israel
Italy
Many Locations, Italy
Russian Federation
Many Locations, Russian Federation
Slovakia
Many Locations, Slovakia
Sweden
Many Locations, Sweden
United Kingdom
Many Locations, United Kingdom
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01200186     History of Changes
Other Study ID Numbers: 15217, QL0901
Study First Received: August 13, 2010
Last Updated: May 21, 2014
Health Authority: Austria: Ministry of Health
France: French Data Protection Authority
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Finland: Ethics Committee
Greece: Ministry of Health and Welfare
Latvia: State Agency/Medicines and EC
Lithuania: State Agency/Medicines and EC
Czech Republic: Association of Innovative Pharma industry
Germany: The Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Russian Federation: Independent EC - approval; The Ministry of Health - notification
Slovakia: Ethics Committee
Sweden: Regional Ethics Review Board of Uppsala
Israel: Ethics Commission
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Ethinyl Estradiol
Progestins
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014