Women's Health: Amenorrhea/DysmenorrheaNCT03794895
Prediction of Response to IUCD Associated Menorrhagia Using Doppler
A study testing Doppler in people with Women's Health: Amenorrhea/Dysmenorrhea, run by Ain Shams University at 1 site in Egypt.
Trial summary
Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Women's Health: Amenorrhea/Dysmenorrhea
- What is being tested?
- Doppler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2017to 1 May 2018
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women in chile bearing period (age 20-35 yrs ) with history of regular menstrual cycle presenting with recent onset of more then three months menorrhagia after IUCD "copper T 380 A" insertion
Who cannot join
- history of bleeding tendency
- history of abnormal uterine bleeding due to other causes
- history of active liver disease
- history of antiplatelet or anticoagulant intake in the last month
- history of thyroid disease
- history of endometritis
Show all 10Show fewer
- history of allergy to NSAIDs
- Adenomyosis
- women having contraindications to use NSAIDs e.g. peptic ulcer
- Insulin dependant diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Efficacy of Uterine Artery Doppler in Predicting the Response to Mefenamic Acid During Treatment of Women With IUCD Associated Menorrhagia
Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia
- Conditions
- Women's Health: Amenorrhea/Dysmenorrhea
- Being tested
- Doppler
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopplerDevice
Doing doppler for women having IUCD associated menorrhagia
| Study group | Role | What they receive |
|---|---|---|
| Single arm clinical trial | Experimental | Not described Receives: Device: Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance index and Pulsitality index (Predicting the response to IUCD associated menorrhagia)
Base line uterine artery doppler is done to the patient complaining of IUCD related menorrhagia prior to treatment , parameters of doppler are: resistance index and pulsitality index, then the patient takes mefenamic acid tablets 500 mg three times daily for five days, assessment of response whether the patient is responder or not is done using pictorial blood loss assessment chart then base line doppler parameters in responders and non responders are compared to correlate the response to base line doppler parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start1 May 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's Health: Amenorrhea/DysmenorrheaStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Essam Eldin Mohamed Mohamed Ismail, Ain Shams University
- Investigators
- Yasmine Es Ismail, Bachelor, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794895
- Sponsor's protocol ID
- Yasmine's Protocol
- Status last verified
- Jan 2019
- First submitted
- 27 Dec 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of Uterine Artery Doppler in Predicting the Response to Mefenamic Acid During Treatment of Women With IUCD Associated Menorrhagia
- ClinicalTrials.gov ID
- NCT03794895
- Acronym / sponsor ID
- Yasmine's Protocol
- Conditions
- Women's Health: Amenorrhea/Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 7 Jan 2019 (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.
Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm clinical trial | Experimental | Device: Doppler |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women in chile bearing period (age 20-35 yrs ) with history of regular menstrual cycle presenting with recent onset of more then three months menorrhagia after IUCD "copper T 380 A" insertion
Key exclusion criteria (10 listed)
- history of bleeding tendency
- history of abnormal uterine bleeding due to other causes
- history of active liver disease
- history of antiplatelet or anticoagulant intake in the last month
- history of thyroid disease
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 |
|---|---|---|
| DopplerDoing doppler for women having IUCD associated menorrhagia | Device | Single arm clinical trial |
Primary outcome
Resistance index and Pulsitality index (Predicting the response to IUCD associated menorrhagia)
Time frame: 1 year
Base line uterine artery doppler is done to the patient complaining of IUCD related menorrhagia prior to treatment , parameters of doppler are: resistance index and pulsitality index, then the patient takes mefenamic acid tablets 500 mg three times daily for five days, assessment of response whether the patient is responder or not is done using pictorial blood loss assessment chart then base line doppler parameters in responders and non responders are compared to correlate the response to base line doppler parameters
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 7 Jan 2019.
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.
Yasmine Es Ismail, Bachelor principal investigator
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 Doppler in people with Women's Health: Amenorrhea/Dysmenorrhea, 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 1 inclusion and 10 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 7 Jan 2019. 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?
Resistance index and Pulsitality index (Predicting the response to IUCD associated menorrhagia) (time frame: 1 year). 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 7 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.