Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Acceptability of Long-term Progestin-only Contraception in Europe

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: June 30, 2009
Last updated: December 22, 2013
Last verified: December 2013
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.

Condition Intervention
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Drug: Implanon (Etonogestrel)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acceptability of Long-term Progestin-only Contraception in Europe

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Continuation rate [ Time Frame: At 24 months ]

Secondary Outcome Measures:
  • Continuation rate [ Time Frame: At 12 months ]
  • Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient) [ Time Frame: Initial and after 3, 6, 12 and 24 months ]
  • Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons [ Time Frame: At 24 months ]
  • Incidence of Adverse Events, Serious Adverse Events [ Time Frame: During 24 months ]
  • The return to fertility of women discontinuing the method for wish for pregnancy [ Time Frame: 12 months after discontinuation ]

Enrollment: 436
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Patients under daily life treatment receiving Mirena according to local drug information.
Group 2 Drug: Implanon (Etonogestrel)
Patients under daily life treatment receiving Implanon according to local drug information.


Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged 20-35 years switching from short-acting hormonal contraception

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
  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 identifier: NCT00931827

Many Locations, France
Many Locations, Ireland
Many Locations, Slovakia
United Kingdom
Many Locations, United Kingdom
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00931827     History of Changes
Other Study ID Numbers: 14688
MA0801 ( Other Identifier: company internal )
14239 ( Other Identifier: company internal )
14177 ( Other Identifier: company internal )
14176 ( Other Identifier: company internal )
14016 ( Other Identifier: company internal )
Study First Received: June 30, 2009
Last Updated: December 22, 2013

Keywords provided by Bayer:

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on April 24, 2017