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

Study Overview
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Brief Summary
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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).

Official Title
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Tranexamic Acid Versus Depot-Medroxyprogesterone Acetate in the Treatment of Perimenopausal Irregular Uterine Bleeding: Randomized Clinical Trial

Conditions
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Uterine Bleeding

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Medroxyprogesterone Acetate 150 MG/ML


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tranexamic acid group<br>will tranexamic acid 500 mg 4 times daily in one group, | Drug: Tranexamic acid<br>* 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.<br>|
| Other: Medroxyprogesterone acetate<br>will receive 150mg of medroxyprogesterone acetate once intramuscular. | Drug: Medroxyprogesterone Acetate 150 MG/ML<br>* will be given MPA at 150 mg once intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bleeding days |  | 6 months |