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

NCT02616731 | Unknown Phase 1 DMC

• 1 other identifier: TXAvsDiosmin-IUDmenorrhagia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Menorrhagia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

Drug: Tranexamic Acid

Diosmin

ACTIVE COMPARATOR

Drug: Diosmin

Interventions

Tranexamic Acid 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

Also known as: kapron

Tranexamic acid

Diosmin 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

Also known as: dycinon

Diosmin

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Alanwar

Cairo, Cairo Governorate, 11331, Egypt

RECRUITING

MeSH Terms

Conditions

Menorrhagia

Interventions

Tranexamic Acid; Diosmin

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

ahmed alanwar, MD

CONTACT

+201111486669; eladwar@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: November 30, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

EG (1)