Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss

Assiut University

Status and phase: Unknown; Phase 3

Conditions: Menorrhagia

Treatments: Drug: Tranexamic Acid 500 MG; Drug: Calcium Dobesilate

Study type: Interventional

Funder types: Other

Identifiers

NCT03139422

TA

Details and patient eligibility

About

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%.

Enrollment: 140 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Tranexamic Acid

Active Comparator group

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

Treatment:

Drug: Tranexamic Acid 500 MG

Calcium Dobesilate

Experimental group

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.

Treatment:

Drug: Calcium Dobesilate