Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss
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.
1 other identifier
interventional
140
1 country
1
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 27, 2018
June 1, 2018
1.3 years
April 30, 2017
June 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of women requesting treatment for heavy menstrual blood loss.
3 months
Study Arms (2)
Tranexamic Acid
ACTIVE COMPARATORTranexamic 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
EXPERIMENTALCalcium Dobesilate oral tablets 500 mg (three times daily) with the onset of the first day of menstrual cycle till the end of bleeding.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Refusing to participate.
- Irregular menstrual cycle.
- Misplaced Intrauterine device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut Faculty of Medicine
Asyut, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
April 30, 2017
First Posted
May 4, 2017
Study Start
July 1, 2017
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
June 27, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share