Dysfunctional Uterine BleedingPhase 3NCT04290013
Effects of Tranexemic Acid Versus Norethisterone Acetate on Endometrial Vasculature .
A Phase 3 study testing norethisterone acetate and tranexamic acid tablets in people with Dysfunctional Uterine Bleeding, run by Cairo University.
Trial summary
Heavy periods is a significant problem in reproductive age .It affects about a third of women in the childbearing period Any of the following is considered to be heavy menstrual bleeding (Bleeding that lasts more than 7 days,Bleeding that soaks through one or more tampons or pads every hour for several hours in a… Read more about this study
- Who is it for?
- Ages 35 to 49 years, women only
- Conditions the study is for
- Dysfunctional Uterine Bleeding
- What is being tested?
- norethisterone acetate and tranexamic acid tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2020to 31 Dec 2020
- Phase
- Phase 3
- 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 35 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 35-49 years old.
- Normal gynecologic and breast examination
- Women who have sterilization or husband is sterilized or accepts to use a suitable barrier contraception during the duration of the study.
- Heavy periods (were assessed by validated pictorial blood chart)
- Normal ultrasound, hysteroscopy and endometrial biopsy.
- Normal coagulation profile and thyroid function.
- No contraindication to tranexamic acid or Norethisterone acetate : allergy,History of arterial or venous thromboembolic disease,Disturbance of liver function or Severe renal impairment.
Who cannot join
- Women who are less than 35 years old or more than 49 years old.
- Women who had organic cause for heavy periods as uterine polypi,fibroids or endometriosis.
- Women taking hormonal preparation the month before starting the trial.
- Women with abnormal findings in pelvic ultrasound,hysteroscopy or endometrial biopsy.
- Women who suffer from uncontrolled diabetes or uncontrolled hypertension.
- Women with history of breast cancer or precancerous conditions.
Trial locations and contacts
No sites are listed yet.
Yasser Khamis, MD contact
About this study
Official title: Effect of Tranexemic Acid and Norethisterone Acetate on Endometrial Vasculature in Women With Dysfunctional Uterine Bleeding.
Heavy periods is a significant problem in reproductive age .It affects about a third of women in the childbearing period
Any of the following is considered to be heavy menstrual bleeding (Bleeding that lasts more than 7 days,Bleeding that soaks through one or more tampons or pads every hour for several hours in a row.Needing to wear more than one pad at a time to control menstrual flow.,Needing to change pads or tampons during the night or Menstrual flow with blood clots that are as big as a quarter or larger) .
Read more
Heavy periods can be caused by organic cause as fibroids, adenomyosis, polyps or they can be dysfunctional.Dysfunctional uterine bleeding is irregular uterine bleeding that occurs in the absence of recognisable pelvic pathology, general medical disease, or pregnancy. It reflects a disruption in the normal cyclic pattern of ovulatory hormonal stimulation to the endometrial lining.
Several treatment options include: hormonal treatment as norethisterone acetate,oral contraceptive pills, gonadotrophin releasing hormone analogue. ,tranexamic acid or non steroidal anti-inflammatory drugs.
The investigators plan to do a comparative study between norethisterone acetate and tranexamic acid regarding their control of the heavy periods as well as their effect on the uterine and endometrial vasculature.
Read the detailed description
This is a Randomised controlled trial.The investigators will randomise 120 women who suffer from heavy periods (age range 35-49 years old) without organic cause (Dysfunctional bleeding ) into 2 groups, group A (60 women) : They will take norethisterone acetate 15 mg daily from day 5 to day 26 of the period for 3 months.
Group B (60 women): They will take 1 gm tranexemic acid three times daily from the start of menstrual period up to 5 days.The dose might be increased per day (Not more than 4 gm per day).
The investigators will check endometrial thickness, endometrial volume, uterine artery Doppler indices as well as endometrial and subendometrial indices before starting the treatment and 3 months afterwards.
- Conditions
- Dysfunctional Uterine Bleeding
- Being tested
- norethisterone acetate, tranexamic acid tablets
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norethisterone acetateDrug
norethisterone acetate 15 mg daily from day 5 of the cycle to day 26.
tranexamic acid tabletsDrug
tranexemic acid 1 gm three times daily from the first day of the menstrual cycle up to 5 days .The dose can be increased but not exceeding 4 gm per day.
| Study group | Role | What they receive |
|---|---|---|
| norethisterone -women with Dysfunctional uterine bleeding | Experimental | Not described Receives: Drug: norethisterone acetate |
| tranexemic acid-women with Dysfunctional uterine bleeding | Experimental | Not described Receives: Drug: tranexamic acid tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
reducion of the menstrual flow.
Using Pictorial Blood loss assessment chart depends on counting the sanitary pads and scoring the amount of blood in them)
Measured: 3 months
Secondary outcomes (4)
endometrial thickness in centimetre.
Measurement of the thickest part of the endometrium in centimetres in the longitudinal plan of the uterus using Two- Dimensional Transvaginal ultrasound
Measured: Before the intervention and 3 months afterwards
endometrial volume in cubic centimetre.
Measurement of the endometrial volume in cubic centimetres using Three-Dimensional transvaginal ultrasound
Measured: Before the intervention and 3 months afterwards
uterine artery Doppler indices.
Measurement of the uterine artery Doppler indices using Transvaginal ultrasound and taking the mean for both arteries.
Measured: Before the intervention and 3 months afterwards
endometrial three-dimensional vascular indices.
Measuring the vascularity in the endometrium using power doppler and Three -Dimensional transvaginal ultrasound.
Measured: Before the intervention and 3 months afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start22 Apr 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Elkattan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290013
- Sponsor's protocol ID
- Protocol 400
- Status last verified
- Mar 2020
- First submitted
- 23 Feb 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexemic Acid and Norethisterone Acetate on Endometrial Vasculature in Women With Dysfunctional Uterine Bleeding.
- ClinicalTrials.gov ID
- NCT04290013
- Acronym / sponsor ID
- Protocol 400
- Conditions
- Dysfunctional Uterine Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Apr 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Feb 2020 (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.
Heavy periods is a significant problem in reproductive age .It affects about a third of women in the childbearing period
Any of the following is considered to be heavy menstrual bleeding (Bleeding that lasts more than 7 days,Bleeding that soaks through one or more tampons or pads every hour for several hours in a row.Needing to wear more than one pad at a time to control menstrual flow.,Needing to change pads or tampons during the night or Menstrual flow with blood clots that are as big as a quarter or larger) .
Heavy periods can be caused by organic cause as fibroids, adenomyosis, polyps or they can be dysfunctional.Dysfunctional uterine bleeding is irregular uterine bleeding that occurs in the absence of recognisable pelvic pathology, general medical disease, or pregnancy. It reflects a disruption in the normal cyclic pattern of ovulatory hormonal stimulation to the endometrial lining.
Several treatment options include: hormonal treatment as norethisterone acetate,oral contraceptive pills, gonadotrophin releasing hormone analogue. ,tranexamic acid or non steroidal anti-inflammatory drugs.
The investigators plan to do a comparative study between norethisterone acetate and tranexamic acid regarding their control of the heavy periods as well as their effect on the uterine and endometrial vasculature.
Detailed description
This is a Randomised controlled trial.The investigators will randomise 120 women who suffer from heavy periods (age range 35-49 years old) without organic cause (Dysfunctional bleeding ) into 2 groups, group A (60 women) : They will take norethisterone acetate 15 mg daily from day 5 to day 26 of the period for 3 months.
Group B (60 women): They will take 1 gm tranexemic acid three times daily from the start of menstrual period up to 5 days.The dose might be increased per day (Not more than 4 gm per day).
The investigators will check endometrial thickness, endometrial volume, uterine artery Doppler indices as well as endometrial and subendometrial indices before starting the treatment and 3 months afterwards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| norethisterone -women with Dysfunctional uterine bleeding | Experimental | Drug: norethisterone acetate |
| tranexemic acid-women with Dysfunctional uterine bleeding | Experimental | Drug: tranexamic acid tablets |
Who may qualify
- Ages
- 35 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 35-49 years old.
- Normal gynecologic and breast examination
- Women who have sterilization or husband is sterilized or accepts to use a suitable barrier contraception during the duration of the study.
- Heavy periods (were assessed by validated pictorial blood chart)
- Normal ultrasound, hysteroscopy and endometrial biopsy.
Key exclusion criteria (6 listed)
- Women who are less than 35 years old or more than 49 years old.
- Women who had organic cause for heavy periods as uterine polypi,fibroids or endometriosis.
- Women taking hormonal preparation the month before starting the trial.
- Women with abnormal findings in pelvic ultrasound,hysteroscopy or endometrial biopsy.
- Women who suffer from uncontrolled diabetes or uncontrolled hypertension.
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 |
|---|---|---|
| norethisterone acetatenorethisterone acetate 15 mg daily from day 5 of the cycle to day 26. | Drug | norethisterone -women with Dysfunctional uterine bleeding |
| tranexamic acid tabletstranexemic acid 1 gm three times daily from the first day of the menstrual cycle up to 5 days .The dose can be increased but not exceeding 4 gm per day. | Drug | tranexemic acid-women with Dysfunctional uterine bleeding |
Primary outcome
reducion of the menstrual flow.
Time frame: 3 months
Using Pictorial Blood loss assessment chart depends on counting the sanitary pads and scoring the amount of blood in them)
4 secondary outcomes
endometrial thickness in centimetre.
Time frame: Before the intervention and 3 months afterwards
endometrial volume in cubic centimetre.
Time frame: Before the intervention and 3 months afterwards
uterine artery Doppler indices.
Time frame: Before the intervention and 3 months afterwards
endometrial three-dimensional vascular indices.
Time frame: Before the intervention and 3 months afterwards
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- 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.
Yasser Khamis, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing norethisterone acetate and tranexamic acid tablets in people with Dysfunctional Uterine Bleeding, run by Cairo University.
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 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Eman Elkattan, MD,MRCOG,DFSRH (01212529213, emyelkattan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reducion of the menstrual flow. (time frame: 3 months). 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 16 Mar 2020.