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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 July 2016 |
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Main ID: |
NCT02736019 |
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Date of registration:
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08/04/2016 |
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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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Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women
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Scientific title:
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Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women: A Double Blind Randomized Controlled Trial |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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210 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02736019 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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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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AbdelGany M Hassan, MRCOG, MD |
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Address:
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Telephone:
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+201017801604 |
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Email:
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abdelgany2@gmail.com |
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Affiliation:
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Name:
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AbdelGany MA Hassan, MRCOG, MD |
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Address:
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Telephone:
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00217801604 |
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Email:
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abdelgany2@gmail.com |
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Affiliation:
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Name:
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AbdelGany M Hassan |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Post menopausal women.
- vaginal bleeding.
- Endometrial thickness >4mm.
Exclusion Criteria:
- Medical disorders like uncontrolled diabetes or hypertension, cardiac, renal , liver
disease.
- Gastritis or peptic ulcer.
- Allergy to Tramadol or Celecoxib.
Age minimum:
50 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hysteroscopy
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Intervention(s)
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Drug: Placebo 2
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Drug: Placebo 1
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Drug: Celecoxib
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Drug: Tramadol
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Primary Outcome(s)
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Patient's perception of pain during the procedure
[Time Frame: 2 minutes after starting the procedure]
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Secondary Outcome(s)
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Pain after the procedure
[Time Frame: 30 minutes after completing the procedure]
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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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