Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss

Phase 3

• Conditions: Menorrhagia
• Interventions: Drug: Tranexamic Acid 500 MG; Drug: Calcium Dobesilate

• Registration Number: NCT03139422
• Lead Sponsor: Assiut University

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%.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-30
• Study First Submitted QC: 2017-04-30
• Study First Posted: 2017-05-04
• Study Start: 2017-07-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

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

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Exclusion Criteria

1. Refusing to participate.
2. Irregular menstrual cycle.
3. Misplaced Intrauterine device.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic Acid 500 MG	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	Calcium Dobesilate	Calcium Dobesilate oral tablets 500 mg (three times daily) with the onset of the first day of menstrual cycle till the end of bleeding.

Primary Outcome Measures

Name	Time	Method
Percent of women requesting treatment for heavy menstrual blood loss.	3 months

Trial Locations

Locations (1)

Assiut Faculty of Medicine; 🇪🇬 Assiut, Egypt