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

Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD: Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Menorrhagia
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Diosmin

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: ahmed alanwar, MD; Phone Number: +201111486669; Email: eladwar@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11331
    • Recruiting
    • Ahmed Alanwar
    • Contact: ahmed alanwar, MD; Phone Number: 002 +201111486669; Email: eladwar@hotmail.com
    • Contact: ahmed kotb, MD; Phone Number: 002 +201008681999; Email: ahmedmkotp@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic acid	Drug: 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; Other Names: kapron
Active Comparator: Diosmin	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; Other Names: dycinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	the first 24hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: November 22, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 30, 2015

Study Record Updates

• Last Update Posted (Estimate): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXAvsDiosmin-IUDmenorrhagia