Tranexamic Acid and Depot-Medroxyprogesterone Acetate for Perimenopausal Irregular Uterine Bleeding

Assiut University (Other)
Overall Status
Recruiting ID

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic acid
  • Drug: Medroxyprogesterone Acetate 150 MG/ML

Study Design

Study Type:
Anticipated Enrollment :
110 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Tranexamic Acid Versus Depot-Medroxyprogesterone Acetate in the Treatment of Perimenopausal Irregular Uterine Bleeding: Randomized Clinical Trial
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Tranexamic acid group

will tranexamic acid 500 mg 4 times daily in one group,

Drug: Tranexamic acid
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.

Other: Medroxyprogesterone acetate

will receive 150mg of medroxyprogesterone acetate once intramuscular.

Drug: Medroxyprogesterone Acetate 150 MG/ML
will be given MPA at 150 mg once intramuscular injection

Outcome Measures

Primary Outcome Measures

  1. Number of bleeding days [6 months]

Eligibility Criteria


Ages Eligible for Study:
40 Years to 55 Years
Sexes Eligible for Study:
Accepts 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.

Contacts and Locations


Site City State Country Postal Code
1 Women Health Hospital - Assiut university Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Mohammed Khairy Ali, Assistant professor, Assiut University Identifier:
Other Study ID Numbers:
First Posted:
Jan 14, 2021
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2021