Oral Tranexamic Acid Versus Diosmin for Treatment of Meno... | NCT02616731

Studies
Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD

NCT02616731

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Nov 30, 2015Estimated

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Menorrhagia

Interventions

Tranexamic Acid
Diosmin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jan 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Nov 22, 2015

First Submission Date that Met QC Criteria

Nov 25, 2015

First Posted Date

Nov 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2015

Last Update Posted Date

Nov 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tranexamic acid	Active Comparator		Drug: Tranexamic Acid
Diosmin	Active Comparator		Drug: Diosmin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic Acid	Drug	use tranexamic acid oral tablets 500 mg two tablets every six hour with the onset of the first day of menstrual cycle till the end of bleeding then The amount of menstrual flow will be calculated by the PBAC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The amount of reducing heavy menstrual flow will be calculated by the PBAC.	measure the bleeding rate will be by the pictorial blood assessment chart (PBAC).	the first 24hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women complaining from an menorrhagia secondary to a current copper IUD use.
Age: 20-40years.
Menorrhagia , will be defined as a PBAC-Score greater than 100.
No systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
No other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
No drugs decreasing blood coagulation.
Well fitted IUD not misplaced.

Exclusion Criteria:

Age <20y and >40y.
Irregular menstrual cycle.
Presence of systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
Presence of other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
Taking drugs decrease blood coagulation.
Misplaced IUD.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ahmed alanwar, MD	Contact	+201111486669		eladwar@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Alanwar	Recruiting	Cairo	Cairo Governorate	11331	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D008595	Menorrhagia

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid
D004145	Diosmin

Ancestor Terms

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided