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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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12 December 2020 |
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Main ID: |
NCT03139422 |
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Date of registration:
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30/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss
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Scientific title:
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Tranexamic Acid Versus Calcium Dobesilate for the Treatment of Copper Intra Uterine Contraceptive Device Associated Heavy Menstrual Blood Loss : A Randomized , Open-labelled , Clinical Trial. |
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Date of first enrolment:
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July 1, 2017 |
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Target sample size:
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140 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03139422 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Eriny Morris, MBBCh |
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Address:
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Telephone:
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00201203211136 |
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Email:
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ranamorris76@yahoo.com |
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Affiliation:
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Name:
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Ahmed Abbas, MD |
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Address:
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Telephone:
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Email:
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bmr90@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Women usingsopperT380A and reporting heavy menstrual blood loss during use.
2. Menorrhagia , will be defined as a Pictorial blood loss assessment chart-Score greater
than 100.
3. No contraindication to drugs used in treatment.
4. No other cause for heavy menstrual blood loss
Exclusion Criteria:
1. Refusing to participate.
2. Irregular menstrual cycle.
3. Misplaced Intrauterine device.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Menorrhagia
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Intervention(s)
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Drug: Calcium Dobesilate
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Drug: Tranexamic Acid 500 MG
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Primary Outcome(s)
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Percent of women requesting treatment for heavy menstrual blood loss.
[Time Frame: 3 months]
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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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