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Acceptability of Long-term Progestin-only Contraception in Europe

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00931827
First received: June 30, 2009
Last updated: December 21, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Contraception
 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:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Continuation rate [ Time Frame: At 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Continuation rate [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient) [ Time Frame: Initial and after 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events, Serious Adverse Events [ Time Frame: During 24 months ] [ Designated as safety issue: Yes ]
  • The return to fertility of women discontinuing the method for wish for pregnancy [ Time Frame: 12 months after discontinuation ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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

No publications provided

Responsible Party: Regional Medical Director, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00931827     History of Changes
Other Study ID Numbers: 14688, MA0801, 14239, 14177, 14176, 14016
Study First Received: June 30, 2009
Last Updated: December 21, 2012
Health Authority: France: French Data Protection Authority
United Kingdom: Research Ethics Committee
Ireland: Medical Ethics Research Committee
Slovakia: State Institute for Drug Control

Keywords provided by Bayer:
Contraception

Additional relevant MeSH terms:
Levonorgestrel
3-keto-desogestrel
Progestins
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 21, 2013