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Completed

NCT Number: NCT00931827

Acceptability of Long-term Progestin-only Contraception in Europe

The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.

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Key information

Conditions

Contraception

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged 20-35 in good general health requesting contraception
  • Women who have used short-acting hormonal contraception (combined or progestogen-only pills, vaginal ring or contraceptive patch) for at least 3 cycles immediately before entering the study and opting to change to either Mirena or Implanon for contraception
  • Women who have given a written informed consent to participate in the study (if applicable)

Exclusion criteria

  • The contraindications and warnings of the respective Summary of Product Characteristics (Mirena or Implanon) must be followed. The decision to start Mirena or Implanon has to be made clearly before the decision to include patients in the study
  • Patients who are breast-feeding at time of inclusion for the study will also be excluded since breast-feeding affects the bleeding pattern

Treatment and study plan

Levonorgestrel IUS (Mirena, BAY86-5028)

Drug

Patients under daily life treatment receiving Mirena according to local drug information.

Implanon (Etonogestrel)

Drug

Patients under daily life treatment receiving Implanon according to local drug information.

Primary outcomes

  1. Continuation rate

    Time frame: At 24 months

Secondary outcomes

  1. Continuation rate

    Time frame: At 12 months

  2. Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient)

    Time frame: Initial and after 3, 6, 12 and 24 months

  3. Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons

    Time frame: At 24 months

  4. Incidence of Adverse Events, Serious Adverse Events

    Time frame: During 24 months

  5. The return to fertility of women discontinuing the method for wish for pregnancy

    Time frame: 12 months after discontinuation

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 2, 2009
Registry last updated
Dec 24, 2013

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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