Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss

Menorrhagia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03139422
• Other study ID #: TA
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: Eriny Morris, MBBCh
• Phone: 00201203211136
• Email: ranamorris76[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Drug:
• Tranexamic Acid 500 MG
oral tablets
• Calcium Dobesilate
oral tablets

Locations

Country	Name	City	State
Egypt	Assiut Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of women requesting treatment for heavy menstrual blood loss.		3 months