Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03139422

Collaborator

(none)

140

Enrollment

Location

Arms

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

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%.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Drug: Tranexamic Acid 500 MG Drug: Calcium Dobesilate	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jul 1, 2017

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Tranexamic Acid 500 MG oral tablets
Experimental: 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.	Drug: Calcium Dobesilate oral tablets

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Tranexamic Acid 500 MG

oral tablets

Experimental: 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.

Drug: Calcium Dobesilate

oral tablets

Outcome Measures

Primary Outcome Measures

Percent of women requesting treatment for heavy menstrual blood loss. [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Faculty of Medicine	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03139422

Other Study ID Numbers:

First Posted:

May 4, 2017

Last Update Posted:

Jun 27, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2018