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

A

Assiut University

Status

Completed

Conditions

Uterine Bleeding

Treatments

Drug: Medroxyprogesterone Acetate 150 MG/ML
Drug: Tranexamic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT04710017
TA-DMPA

Details and patient eligibility

About

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).

Enrollment

110 patients

Sex

Female

Ages

40 to 55 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

Tranexamic acid group
Other group
Description:
will tranexamic acid 500 mg 4 times daily in one group,
Treatment:
Drug: Tranexamic acid
Medroxyprogesterone acetate
Other group
Description:
will receive 150mg of medroxyprogesterone acetate once intramuscular.
Treatment:
Drug: Medroxyprogesterone Acetate 150 MG/ML

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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