Tranexamic Acid and Depot-Medroxyprogesterone Acetate for Perimenopausal Irregular Uterine Bleeding
Primary Purpose
Uterine Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid
Medroxyprogesterone Acetate 150 MG/ML
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Bleeding
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed, clinically as peri-menopausal abnormal uterine bleeding with normal pelvic examination.
- Patient's age ranging from 40- 55y.
Exclusion Criteria:
- Post menopausal women
- Presence of fibroids, adenomyosis, polyp, adnexal mass, endometrial hyperplasia with atypia, and breast malignancy).
- Patients with uncontrolled hypertension.
- Patient of abnormal bleeding profile.
- history of liver impairment and renal insufficiency
- Patients seeking for surgical management.
Sites / Locations
- Women Health Hospital - Assiut universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Tranexamic acid group
Medroxyprogesterone acetate
Arm Description
will tranexamic acid 500 mg 4 times daily in one group,
will receive 150mg of medroxyprogesterone acetate once intramuscular.
Outcomes
Primary Outcome Measures
Number of bleeding days
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04710017
Brief Title
Tranexamic Acid and Depot-Medroxyprogesterone Acetate for Perimenopausal Irregular Uterine Bleeding
Official Title
Tranexamic Acid Versus Depot-Medroxyprogesterone Acetate in the Treatment of Perimenopausal Irregular Uterine Bleeding: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Abnormal uterine bleeding is a symptom and not a disease. It is one of the most frequently encountered complaints in gynecologic practice. It accounts for more than 70% of all gynecological consultations in the peri- and post-menopausal age group.
Abnormal uterine bleeding may be acute or chronic and is defined as bleeding from the uterine corpus that is abnormal in regularity, volume, frequency, or duration and occurs in the absence of pregnancy.
Chronic heavy or prolonged uterine bleeding can result in anemia, interfere with daily activities. Iron deficiency anemia develops in 21 to 67 percent of cases and raises concerns about uterine cancer.
According to the International Federation of Obstetrics and Gynecology, the classification of abnormal uterine bleeding is based on PALM-COEIN which is an acronym for various etiologies namely polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic and not otherwise classified (PALM-COEIN).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid group
Arm Type
Other
Arm Description
will tranexamic acid 500 mg 4 times daily in one group,
Arm Title
Medroxyprogesterone acetate
Arm Type
Other
Arm Description
will receive 150mg of medroxyprogesterone acetate once intramuscular.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
will be given Tranexamic acid at 500 mg four times daily (2 g/day) during the bleeding episodes for 5 days. The dose is 250 mg.
Intervention Type
Drug
Intervention Name(s)
Medroxyprogesterone Acetate 150 MG/ML
Intervention Description
will be given MPA at 150 mg once intramuscular injection
Primary Outcome Measure Information:
Title
Number of bleeding days
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed, clinically as peri-menopausal abnormal uterine bleeding with normal pelvic examination.
Patient's age ranging from 40- 55y.
Exclusion Criteria:
Post menopausal women
Presence of fibroids, adenomyosis, polyp, adnexal mass, endometrial hyperplasia with atypia, and breast malignancy).
Patients with uncontrolled hypertension.
Patient of abnormal bleeding profile.
history of liver impairment and renal insufficiency
Patients seeking for surgical management.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed K ALi, MD
Phone
+201005537951
Email
m_khairy2001@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tranexamic Acid and Depot-Medroxyprogesterone Acetate for Perimenopausal Irregular Uterine Bleeding
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