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Completed

NCT Number: NCT01200186

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.

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Key information

Conditions

Contraceptives, Oral

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EV/DNG (Qlaira, BAY86-5027)

Drug

At the discretion of the attending physician

Progestin Only Pills

Drug

At the discretion of the attending physician

Primary outcomes

  1. The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.

    Time frame: up to 12 Months

Secondary outcomes

  1. Time to event for discontinuation due to reasons other than bleeding irregularities

    Time frame: Month 3-5

  2. Time to event for discontinuation due to reasons other than bleeding irregularities

    Time frame: Month 6-12

  3. Number of intracyclic bleeding

    Time frame: Month 3-5

  4. Number of intracyclic bleeding

    Time frame: Month 6-12

  5. Number of heavy and/or prolonged bleeding

    Time frame: Month 3-5

  6. Number of heavy and/or prolonged bleeding

    Time frame: Month 6-12

  7. Number of unintended pregnancies

    Time frame: Month 3-5

  8. Number of unintended pregnancies

    Time frame: Month 6-12

  9. 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

  10. 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

  11. Global assessment of well-being and satisfaction

    Time frame: Month 3-5

  12. Global assessment of well-being and satisfaction

    Time frame: Month 6-12

  13. Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy

    Time frame: up to 12 Months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2010
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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