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

Sponsor
Ain Shams University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02616731
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
6
Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD: Randomized Controlled Trial
Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2016
Anticipated Study Completion Date :
Mar 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmed Alanwar Cairo Egypt 11331

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Alanwar, lecturer, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02616731
    Other Study ID Numbers:
    • TXAvsDiosmin-IUDmenorrhagia
    First Posted:
    Nov 30, 2015
    Last Update Posted:
    Nov 30, 2015
    Last Verified:
    Nov 1, 2015
    Additional relevant MeSH terms:
    Menorrhagia
    Tranexamic Acid

    Study Results

    No Results Posted as of Nov 30, 2015