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Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD

Primary Purpose

Menorrhagia

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic Acid
Diosmin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women complaining from an menorrhagia secondary to a current copper IUD use.
  • Age: 20-40years.
  • Menorrhagia , will be defined as a PBAC-Score greater than 100.
  • No systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
  • No other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
  • No drugs decreasing blood coagulation.
  • Well fitted IUD not misplaced.

Exclusion Criteria:

  • Age <20y and >40y.
  • Irregular menstrual cycle.
  • Presence of systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
  • Presence of other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
  • Taking drugs decrease blood coagulation.
  • Misplaced IUD.

Sites / Locations

  • Ahmed AlanwarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tranexamic acid

Diosmin

Arm Description

Outcomes

Primary Outcome Measures

The amount of reducing heavy menstrual flow will be calculated by the PBAC.
measure the bleeding rate will be by the pictorial blood assessment chart (PBAC).

Secondary Outcome Measures

Full Information

First Posted
November 22, 2015
Last Updated
November 25, 2015
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02616731
Brief Title
Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD
Official Title
Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Title
Diosmin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
kapron
Intervention Description
use tranexamic acid oral tablets 500 mg two tablets every six hour with the onset of the first day of menstrual cycle till the end of bleeding then The amount of menstrual flow will be calculated by the PBAC
Intervention Type
Drug
Intervention Name(s)
Diosmin
Other Intervention Name(s)
dycinon
Intervention Description
use diosmin oral tablets 500 mg t.d.s (three times daily) with the onset of the first day of menstrual cycle till the end of bleeding.then The amount of menstrual flow will be calculated by the PBAC
Primary Outcome Measure Information:
Title
The amount of reducing heavy menstrual flow will be calculated by the PBAC.
Description
measure the bleeding rate will be by the pictorial blood assessment chart (PBAC).
Time Frame
the first 24hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women complaining from an menorrhagia secondary to a current copper IUD use. Age: 20-40years. Menorrhagia , will be defined as a PBAC-Score greater than 100. No systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases. No other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps). No drugs decreasing blood coagulation. Well fitted IUD not misplaced. Exclusion Criteria: Age <20y and >40y. Irregular menstrual cycle. Presence of systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases. Presence of other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps). Taking drugs decrease blood coagulation. Misplaced IUD.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed alanwar, MD
Phone
+201111486669
Email
eladwar@hotmail.com
Facility Information:
Facility Name
Ahmed Alanwar
City
Cairo
ZIP/Postal Code
11331
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed alanwar, MD
Phone
+201111486669
Ext
002
Email
eladwar@hotmail.com
First Name & Middle Initial & Last Name & Degree
ahmed kotb, MD
Phone
+201008681999
Ext
002
Email
ahmedmkotp@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD

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