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Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss

Primary Purpose

Menorrhagia

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Tranexamic Acid 500 MG

Calcium Dobesilate

About this trial

This is an interventional treatment trial for Menorrhagia

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women usingsopperT380A and reporting heavy menstrual blood loss during use.
Menorrhagia , will be defined as a Pictorial blood loss assessment chart-Score greater than 100.
No contraindication to drugs used in treatment.
No other cause for heavy menstrual blood loss

Exclusion Criteria:

Refusing to participate.
Irregular menstrual cycle.
Misplaced Intrauterine device.

Sites / Locations

Assiut Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tranexamic Acid

Calcium Dobesilate

Arm Description

Tranexamic Acid oral tablets 500 mg every six hour with the onset of the first day of menstrual cycle till the end of bleeding for 3 cycles

Calcium Dobesilate oral tablets 500 mg (three times daily) with the onset of the first day of menstrual cycle till the end of bleeding.

Outcomes

Primary Outcome Measures

Percent of women requesting treatment for heavy menstrual blood loss.

Secondary Outcome Measures

Full Information

NCT ID

NCT03139422

First Posted

April 30, 2017

Last Updated

June 26, 2018

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03139422

Brief Title

Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss

Official Title

Tranexamic Acid Versus Calcium Dobesilate for the Treatment of Copper Intra Uterine Contraceptive Device Associated Heavy Menstrual Blood Loss : A Randomized , Open-labelled , Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

October 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Intrauterine contraceptive device is the most commonly reversible method used among women of reproductive age worldwide. Almost one in five married contraceptive users is currently using Intrauterine contraceptive device. The Egyptian demographic and health survey results indicate that 30% of currently married women interviewed in the Egyptian demographic and health survey were using Intrauterine contraceptive device. Main reasons for discontinuation of Intrauterine contraceptive device as cited by women were excessive bleeding per vagina 39.68%, abdominal pain 38.62%, low backache35.97%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menorrhagia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic Acid

Arm Type

Active Comparator

Arm Description

Tranexamic Acid oral tablets 500 mg every six hour with the onset of the first day of menstrual cycle till the end of bleeding for 3 cycles

Arm Title

Calcium Dobesilate

Arm Type

Experimental

Arm Description

Calcium Dobesilate oral tablets 500 mg (three times daily) with the onset of the first day of menstrual cycle till the end of bleeding.

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid 500 MG

Intervention Description

oral tablets

Intervention Type

Drug

Intervention Name(s)

Calcium Dobesilate

Intervention Description

oral tablets

Primary Outcome Measure Information:

Title

Percent of women requesting treatment for heavy menstrual blood loss.

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women usingsopperT380A and reporting heavy menstrual blood loss during use. Menorrhagia , will be defined as a Pictorial blood loss assessment chart-Score greater than 100. No contraindication to drugs used in treatment. No other cause for heavy menstrual blood loss Exclusion Criteria: Refusing to participate. Irregular menstrual cycle. Misplaced Intrauterine device.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eriny Morris, MBBCh

Phone

00201203211136

ranamorris76@yahoo.com

Facility Information:

Facility Name

Assiut Faculty of Medicine

City

Assiut

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Abbas, MD

bmr90@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss

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