MenorrhagiaPhase 1/2NCT02616731
Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD
A Phase 1/2 study testing Tranexamic Acid and Diosmin in people with Menorrhagia, run by Ain Shams University at 1 site in Egypt.
Trial summary
To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Tranexamic Acid and Diosmin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Mar 2016
- Phase
- Phase 1/2
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women complaining from an menorrhagia secondary to a current copper IUD use.
- Age: 20-40years.
- Menorrhagia , will be defined as a PBAC-Score greater than 100.
- No systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
- No other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
- No drugs decreasing blood coagulation.
- Well fitted IUD not misplaced.
Who cannot join
- Age <20y and >40y.
- Irregular menstrual cycle.
- Presence of systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
- Presence of other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
- Taking drugs decrease blood coagulation.
- Misplaced IUD.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Alanwar
Cairo, Cairo Governorate, 11331
ahmed alanwar, MD, +201111486669 ext. 002, eladwar@hotmail.com
ahmed kotb, MD, +201008681999 ext. 002, ahmedmkotp@hotmail.com
About this study
Official title: Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD: Randomized Controlled Trial
To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.
- Conditions
- Menorrhagia
- Being tested
- Tranexamic Acid, Diosmin
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called kapron
use tranexamic acid oral tablets 500 mg two tablets every six hour with the onset of the first day of menstrual cycle till the end of bleeding then The amount of menstrual flow will be calculated by the PBAC
DiosminDrug
Also called dycinon
use diosmin oral tablets 500 mg t.d.s (three times daily) with the onset of the first day of menstrual cycle till the end of bleeding.then The amount of menstrual flow will be calculated by the PBAC
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | Not described Receives: Drug: Tranexamic Acid |
| Diosmin | Active comparator | Not described Receives: Drug: Diosmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of reducing heavy menstrual flow will be calculated by the PBAC.
measure the bleeding rate will be by the pictorial blood assessment chart (PBAC).
Measured: the first 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Alanwar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616731
- Sponsor's protocol ID
- TXAvsDiosmin-IUDmenorrhagia
- Status last verified
- Nov 2015
- First submitted
- 22 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02616731
- Acronym / sponsor ID
- TXAvsDiosmin-IUDmenorrhagia
- Conditions
- Menorrhagia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 30 Nov 2015 (estimated)
- 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.
To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic Acid |
| Diosmin | Active comparator | Drug: Diosmin |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women complaining from an menorrhagia secondary to a current copper IUD use.
- Age: 20-40years.
- Menorrhagia , will be defined as a PBAC-Score greater than 100.
- No systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
- No other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
Key exclusion criteria (6 listed)
- Age <20y and >40y.
- Irregular menstrual cycle.
- Presence of systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
- Presence of other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
- Taking drugs decrease blood coagulation.
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 |
|---|---|---|
| Tranexamic AcidAlso: kapronuse tranexamic acid oral tablets 500 mg two tablets every six hour with the onset of the first day of menstrual cycle till the end of bleeding then The amount of menstrual flow will be calculated by the PBAC | Drug | Tranexamic acid |
| DiosminAlso: dycinonuse diosmin oral tablets 500 mg t.d.s (three times daily) with the onset of the first day of menstrual cycle till the end of bleeding.then The amount of menstrual flow will be calculated by the PBAC | Drug | Diosmin |
Primary outcome
The amount of reducing heavy menstrual flow will be calculated by the PBAC.
Time frame: the first 24hours
measure the bleeding rate will be by the pictorial blood assessment chart (PBAC).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tranexamic Acid and Diosmin in people with Menorrhagia, run by Ain Shams University 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Nov 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed alanwar, MD (+201111486669, eladwar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of reducing heavy menstrual flow will be calculated by the PBAC. (time frame: the first 24hours). 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 30 Nov 2015.