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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 September 2015 |
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Main ID: |
NCT01833793 |
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Date of registration:
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13/03/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice
MARILIA |
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Scientific title:
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Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01833793 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Algeria
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 19-40 years at the time of Mirena IUD insertion
- Using Mirena only for contraception indication
- Never having used the product before
- No heavy menstrual bleeding diagnosed
- Have signed informed consent to participate in this study
Exclusion Criteria:
- Nulliparous
- Pregnancy
- Mirena's contre-indication
- Mirena for HMB
- Abnormal bleeding pattern
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Female Contraception
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Intervention(s)
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Drug: Levonorgestrel IUD (Mirena, BAY86-5028)
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Primary Outcome(s)
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Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users
[Time Frame: 12 months]
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Proportion of Mirena users who have at least one period of Amenorrhea of at least three months
[Time Frame: 12 months]
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Secondary Outcome(s)
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Cumulative rate of satisfaction in Mirena users
[Time Frame: 12 months]
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Proportion of Mirena users who have menstrual disorders
[Time Frame: 12 months]
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Proportion of Mirena users with menorrhagia
[Time Frame: 12 months]
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Secondary ID(s)
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MA1211DZ
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16314
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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