Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-12-31

Brief Summary

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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%.

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Detailed Description

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Conditions

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Menorrhagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tranexamic Acid

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

Group Type ACTIVE_COMPARATOR

Tranexamic Acid 500 MG

Intervention Type DRUG

oral tablets

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.

Group Type EXPERIMENTAL

Calcium Dobesilate

Intervention Type DRUG

oral tablets

Interventions

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Tranexamic Acid 500 MG

oral tablets

Intervention Type DRUG

Calcium Dobesilate

oral tablets

Intervention Type DRUG

Eligibility Criteria

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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