Acceptability of Long-term Progestin-only Contraception in Europe
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| ClinicalTrials.gov Identifier: NCT00931827 |
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Recruitment Status :
Completed
First Posted : July 2, 2009
Last Update Posted : December 24, 2013
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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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 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
| 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. |
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 ]
Information from the National Library of Medicine
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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
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 |
Additional Information:
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| 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:
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Contraception |
Additional relevant MeSH terms:
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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 |