Management of Abnormal Uterine Bleeding

NCT06369012 | Completed DMC

• 1 other identifier: Rania Gamal
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Abnormal uterine bleeding "AUB" describes all abnormal forms of menstrual bleeding which may result from several causes including anovulation, problems related to pregnancy, infections, vaginal and cervical abnormalities, uterine pathologies including benign and malignant tumors, coagulopathies, endocrine disorders, trauma, foreign bodies, systemic diseases and iatrogenic causes. AUB may be clinically presented by menorrhagia, metrorrhagia or menometrorrhagia. It's the most common complaint for the reproductive age females and accounts for 33% of female patients referred to gynecologists

Conditions

Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• Bleeding Control

  The paricipants of the study whom having abnormal uterine bleeding will be asked to take the drugs of the study to see the amount of blood will decrease or not

  1 week

Study Arms (2)

Group A : Mefenamic acid

ACTIVE COMPARATOR

About 65 women will take Mefenamic acid tablets orally, 3 timed per day.This regiment can be repeated for at least three attacks of Abnormal Uterine Bleeding. (Mefenamic acid manufactured by JPI pharmaceutical company)

Drug: Mefenamic acid 500 mg

Group B: Tranexamic acid

ACTIVE COMPARATOR

About 65 women will take Tranexamic acid capsules orally, 3 time per day .This regiment can be repeated for at least three attacks of Abnormal Uterine Bleeding. (Tranexamic acid manufactured by AMOUN pharmaceutical company)

Drug: Mefenamic acid 500 mg

Interventions

Mefenamic acid 500 mg DRUG

To compare the effectiveness of mefenamic acid versus tranexamic acid in the management of abnormal uterine bleeding.

Also known as: Tranexamic Acid 500 mg

Group A : Mefenamic acid; Group B: Tranexamic acid

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any female patient in Child bearing period aging from 15-45 years complaining of Abnormal uterine.
• Abnormal uterine bleeding due to endometrial, uterine cavity lesions as diagnosed by TVS or bleeding tendency e.g. Thrombocytopenia, Platelets dysfunction and coagulation defects

You may not qualify if:

• Personal history of renal or hepatic impairment; previous thromboembolic disease, peptic ulcer.
• Females with evident drugs intake that cause AUB e.g warfarin, low molecular weight heparin.
• Vaginal, vulvar, and cervical causes of bleeding.
• Bleeding on top of Use of hormonal and non-hormonal contraception.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Mefenamic Acid; Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cyclohexanecarboxylic Acids

Study Officials

• Omnia Bakar Bakar, Lecturer

  Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 16, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 30, 2024
• Last Updated: September 3, 2025

Record last verified: 2024-04

Locations

EG (1)