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

Phase 1

• Conditions: Menorrhagia
• Interventions: Drug: Tranexamic Acid; Drug: Diosmin

• Registration Number: NCT02616731
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2015-11
• Study First Submitted: 2015-11-22
• Study First Submitted QC: 2015-11-25
• Last Update Submitted: 2015-11-25
• Study First Posted: 2015-11-30
• Last Update Posted: 2015-11-30
• Primary Completion: 2016-01
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid	-
Diosmin	Diosmin	-

Primary Outcome Measures

Name	Time	Method
The amount of reducing heavy menstrual flow will be calculated by the PBAC.	the first 24hours	measure the bleeding rate will be by the pictorial blood assessment chart (PBAC).

Trial Locations

Locations (1)

Ahmed Alanwar; 🇪🇬 Cairo, Egypt