Abnormal Uterine BleedingNCT06369012
Management of Abnormal Uterine Bleeding
A study testing Mefenamic acid 500 mg in people with Abnormal Uterine Bleeding, run by Egymedicalpedia at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- Mefenamic acid 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Mefenamic Acid Versus Tranexamic Acid in Management of Abnormal Uterine Bleeding
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
Read the detailed description
Menorrhagia, if repeated, causes a decrease in iron reserve and anemia and subsequently, anemia causes psychological and cardiac complications and dysfunction in other organs. So, paying attention to menorrhagia and its treatment can lead to lower morbidity in reproductive aged women. It is worth noticing that most of the iron deficient anemia morbidities are the result of more than 60 ml bleeding per cycle.
The evaluation of the actual bleeding volume is not an easy task because women's evaluation of their own bleeding volume is not reliable. 25% of the women who consider their bleeding level as high had menstrual bleeding less than 35 ml. The estimation of blood loss volume was done based on the number of pads or tampons soaking per day or per cycle. The patient's estimations of the bleeding volumes are not accurate and reliable because they are not well aware of the normal range of bleeding and their evaluations are inexact.
Ideally, a noninvasive investigation is preferred to an invasive one and also an economical investigation preferred to an expensive one; this applies equally to affluent countries and third world, that is why ultrasonography by any modality if available is considered to be a noninvasive procedure to investigate uterine lesions rather than hysteroscopy as a preliminary step .
Various imaging techniques are used to enable the precise localization and characterization of uterine pathology. Currently, the main diagnostic tools for AUB include ultrasonography and diagnostic hysteroscopy.
Menorrhagia is defined as complaint of heavy menstrual bleeding over several consecutive cycles. The upper limit of monthly bleeding is 80 ml per cycle, which is 2 standard deviations from the mean (mean menstrual bleeding per cycle is 36 - 52ml).
Worldwide use of hormonal therapy is based on the wrong assumption that menorrhagia happens because of imbalance in hormones and an ovulatory cycle, but the fact is most of the women with abnormal bleeding show no evidence of hormonal imbalance and based on some studies 95% have regular ovulatory cycles.
Antifibrinolytic medications, such tranexamic acid, function by inhibiting the breakdown of fibrin and are useful in the management of individuals with persistent AUB. It has been demonstrated that they can cut bleeding in these patients by 30 to 55%. For the treatment of acute AUB, experts advise utilizing tranexamic acid intravenously (IV) or orally.
In another study, the treatment of menorrhagia, by both mefenamic acid and tranexamic acid.they were beneficial in controlling menstrual blood loss with significant decrease in dysmenorrhea Minor side effects like epigastric pain, nausea, vomiting was more frequent in mefenamic acid group. Acceptability rate was high in both groups
- Conditions
- Abnormal Uterine Bleeding
- Being tested
- Mefenamic acid 500 mg
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mefenamic acid 500 mgDrug
Also called Tranexamic Acid 500 mg
To compare the effectiveness of mefenamic acid versus tranexamic acid in the management of abnormal uterine bleeding.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Mefenamic acid 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omnia Bakar Bakar, Lecturer, Principal investigator, Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369012
- Sponsor's protocol ID
- Rania Gamal
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Mefenamic Acid Versus Tranexamic Acid in Management of Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT06369012
- Acronym / sponsor ID
- Rania Gamal
- Conditions
- Abnormal Uterine Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Menorrhagia, if repeated, causes a decrease in iron reserve and anemia and subsequently, anemia causes psychological and cardiac complications and dysfunction in other organs. So, paying attention to menorrhagia and its treatment can lead to lower morbidity in reproductive aged women. It is worth noticing that most of the iron deficient anemia morbidities are the result of more than 60 ml bleeding per cycle.
The evaluation of the actual bleeding volume is not an easy task because women's evaluation of their own bleeding volume is not reliable. 25% of the women who consider their bleeding level as high had menstrual bleeding less than 35 ml. The estimation of blood loss volume was done based on the number of pads or tampons soaking per day or per cycle. The patient's estimations of the bleeding volumes are not accurate and reliable because they are not well aware of the normal range of bleeding and their evaluations are inexact.
Ideally, a noninvasive investigation is preferred to an invasive one and also an economical investigation preferred to an expensive one; this applies equally to affluent countries and third world, that is why ultrasonography by any modality if available is considered to be a noninvasive procedure to investigate uterine lesions rather than hysteroscopy as a preliminary step .
Various imaging techniques are used to enable the precise localization and characterization of uterine pathology. Currently, the main diagnostic tools for AUB include ultrasonography and diagnostic hysteroscopy.
Menorrhagia is defined as complaint of heavy menstrual bleeding over several consecutive cycles. The upper limit of monthly bleeding is 80 ml per cycle, which is 2 standard deviations from the mean (mean menstrual bleeding per cycle is 36 - 52ml).
Worldwide use of hormonal therapy is based on the wrong assumption that menorrhagia happens because of imbalance in hormones and an ovulatory cycle, but the fact is most of the women with abnormal bleeding show no evidence of hormonal imbalance and based on some studies 95% have regular ovulatory cycles.
Antifibrinolytic medications, such tranexamic acid, function by inhibiting the breakdown of fibrin and are useful in the management of individuals with persistent AUB. It has been demonstrated that they can cut bleeding in these patients by 30 to 55%. For the treatment of acute AUB, experts advise utilizing tranexamic acid intravenously (IV) or orally.
In another study, the treatment of menorrhagia, by both mefenamic acid and tranexamic acid.they were beneficial in controlling menstrual blood loss with significant decrease in dysmenorrhea Minor side effects like epigastric pain, nausea, vomiting was more frequent in mefenamic acid group. Acceptability rate was high in both groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : Mefenamic acid | Active comparator | Drug: Mefenamic acid 500 mgAbout 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) |
| Group B: Tranexamic acid | Active comparator | Drug: Mefenamic acid 500 mgAbout 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) |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mefenamic acid 500 mgAlso: Tranexamic Acid 500 mgTo compare the effectiveness of mefenamic acid versus tranexamic acid in the management of abnormal uterine bleeding. | Drug | Group A : Mefenamic acid, Group B: Tranexamic acid |
Primary outcome
Bleeding Control
Time frame: 1 week
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omnia Bakar Bakar, Lecturer principal investigator
Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mefenamic acid 500 mg in people with Abnormal Uterine Bleeding, run by Egymedicalpedia at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding Control (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.