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

NCT ID: NCT02616731

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Menorrhagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tranexamic acid

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

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

Diosmin

Group Type ACTIVE_COMPARATOR

Diosmin

Intervention Type DRUG

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

Interventions

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Tranexamic Acid

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

Diosmin

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

Intervention Type DRUG

Other Intervention Names

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kapron dycinon

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Alanwar

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Alanwar

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed alanwar, MD

Role: CONTACT

Phone: +201111486669

Email: [email protected]

Facility Contacts

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ahmed alanwar, MD

Role: primary

ahmed kotb, MD

Role: backup

Other Identifiers

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TXAvsDiosmin-IUDmenorrhagia

Identifier Type: -

Identifier Source: org_study_id