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Clinical trial of Medroxyprogestrone acetate and Tranexamic acid in women with menorrhagia

Protocol summary

Summary
This is a double blind, controlled trial to explore the effects of Medroxyprogestrone acetate and Tranexamic acid on menstrual blood loss volume, Quality of life, and duration of menstrual cycle. 76 women, aged 20-45 years old, with regular cycles who complain of heavy menstrual bleeding are randomly allocated to receive Tranexamic, 500mg Q6h, days 1-5 of menstrual cycle, or Medroxyprogestrone acetate , 5mg Q12h, days 5-26 of menstrual cycles. The menstrual blood volume, quality of life, and side effects of drugs are measured and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138802131641N3
Registration date: 2010-05-29, 1389/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Azita Goshtasebi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3589
Email address
goshtasebi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Research office of Tarbiat Modares University
Expected recruitment start date
2009-03-02, 1387/12/12
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Medroxyprogestrone acetate and Tranexamic acid in women with menorrhagia
Public title
Clinical trial of Medroxyprogestrone acetate and Tranexamic acid in women with menorrhagia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 20-45 years old, Regular menses, Heavy menstrual bleeding in several cycles, BMI 19-29 Exclusion criteria: Irregular menses or intra menstrual bleeding, Existence of uterine fibroids>3cm or other pathologic or iatrogenic causes for abnormal bleeding, Any systemic disease affecting menstrual bleeding, Using hormonal drugs (includes OCPs) or other drugs which influence on menstrual bleeding, Having intra uterine device, Pregnancy, Anemia (Hb<11), any therapeutic or preventive regimes for iron deficiency anemia
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Department Ethics Committee of Tarbiat Modares University
Street address
Medical building1, Tarbiat Modares university, Nasr bridge,
City
Tehran
Postal code
14117-13116
Approval date
empty
Ethics committee reference number
15082873

Health conditions studied

1

Description of health condition studied
menorrhagia
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle

Primary outcomes

1

Description
menstrual blood loss
Timepoint
one, two and three cycles after intervention
Method of measurement
by using pictorial blood loss assessment chart

Secondary outcomes

1

Description
quality of life
Timepoint
before and after intervention
Method of measurement
by using Aberdeen menorrhagia Questionnaire

Intervention groups

1

Description
Tranexamic acid, 500mg, Q6h, days1-5 of menstrual cycle.
Category
Treatment - Drugs

2

Description
Medroxyprogestrone asetate, 5 mg, Q12h, days 5-26 menstrual cycle
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran East Health Center
Full name of responsible person
Somayeh Moukhah
Street address
No. 91, Ardestani Ave., 17 Shahrivar Jonoobi Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Asisstant of Tarbiat Modares University
Full name of responsible person
Dr Azita Goshtasebi
Street address
Tarbiat Modares University, Nasr bridge,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Asisstant of Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Azita Goshtasebi
Position
member of Midwifery Faculty/ Doctoral
Other areas of specialty/work
Street address
Floor3, Medical building3, Tarbiat Modares University, Nasr bridge
City
Tehran
Postal code
Phone
+98 21 8288 3589
Fax
Email
goshtasebi@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Azita Goshtasebi
Position
Ph.D/ member of Midwifery Faculty
Other areas of specialty/work
Street address
Floor3, Medical building3, Tarbiat Modares University
City
Tehran
Postal code
13116-14117
Phone
+98 21 8288 3589
Fax
Email
Goshtasebi@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Somayeh Moukhah
Position
Master of Midwifery
Other areas of specialty/work
Street address
No. 91, Ardestani Av, 17 Shahrevar Jonobi Av, Tehran
City
Tehran
Postal code
17916-84434
Phone
+98 21 3343 5490
Fax
Email
so.moukhah@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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