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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Bleeding

Eligibility Criteria

40 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
January 12, 2021
Last Updated
August 27, 2021
Sponsor
Assiut University
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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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