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

Menorrhagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02616731
• Other study ID #: TXAvsDiosmin-IUDmenorrhagia
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 22, 2015
• Last updated: November 25, 2015
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: November 2015
• Source: Ain Shams University
• Contact: ahmed alanwar, MD
• Phone: +201111486669
• Email: eladwar[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Ahmed Alanwar	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes