Acceptability of Long-term Progestin-only Contraception in Europe
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00931827
First received: June 30, 2009
Last updated: December 21, 2012
Last verified: December 2012
| Tracking Information | |||||
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| First Received Date ICMJE | June 30, 2009 | ||||
| Last Updated Date | December 21, 2012 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Continuation rate [ Time Frame: At 24 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Continuation rate [ Time Frame: During 12 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00931827 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acceptability of Long-term Progestin-only Contraception in Europe | ||||
| Official Title ICMJE | Acceptability of Long-term Progestin-only Contraception in Europe | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Women aged 20-35 years switching from short-acting hormonal contraception |
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| Condition ICMJE | Contraception | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 436 | ||||
| Completion Date | November 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 20 Years to 35 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France, Ireland, Slovakia, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00931827 | ||||
| Other Study ID Numbers ICMJE | 14688, MA0801, 14239, 14177, 14176, 14016 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Regional Medical Director, Bayer HealthCare AG | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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