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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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19 February 2015 |
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Main ID: |
NCT01173965 |
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Date of registration:
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02/08/2010 |
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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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Endometrial Ablation With Non-hysteroscopic Methods
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Scientific title:
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Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®) |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01173965 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Greece
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women presenting with dysfunctional uterine bleeding having completed their family
planning(no wish for further childbearing)
Exclusion Criteria:
- Endometrial pathology
- FSH > 20 day 2 -day 3 of the cycle
- Clotting Disorders
- Thyroid Dysfunction
Age minimum:
30 Years
Age maximum:
49 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Dysfunctional Uterine Bleeding
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Intervention(s)
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Device: MEA
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Device: Novasure
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Primary Outcome(s)
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Amenorrhoea rates one year after intervention
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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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