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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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02616731
Enrollment
100
Registered
2015-11-30
Start date
2015-09-30
Completion date
2016-03-31
Last updated
2015-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia

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.

Interventions

DRUGTranexamic 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

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The amount of reducing heavy menstrual flow will be calculated by the PBAC.the first 24hoursmeasure the bleeding rate will be by the pictorial blood assessment chart (PBAC).

Countries

Egypt

Contacts

Primary Contactahmed alanwar, MD
eladwar@hotmail.com+201111486669

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026