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Acceptability of Long-term Progestin-only Contraception in Europe

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ClinicalTrials.gov Identifier: NCT00931827
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Contraception Drug: Levonorgestrel IUS (Mirena, BAY86-5028) Drug: Implanon (Etonogestrel)

Study Design
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Study Type : Observational
Actual Enrollment : 436 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acceptability of Long-term Progestin-only Contraception in Europe
Study Start Date : January 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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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
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931827


Locations
France
Many Locations, France
Ireland
Many Locations, Ireland
Slovakia
Many Locations, Slovakia
United Kingdom
Many Locations, United Kingdom
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

Responsible Party: Bayer
ClinicalTrials.gov 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 )
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by Bayer:
Contraception

Additional relevant MeSH terms:
Levonorgestrel
Etonogestrel
Progestins
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists