Abnormal Uterine BleedingNCT05153928
Management of Uterine Leiomyomata and Adenomyosis
An observational study of Abnormal Uterine Bleeding, run by Ahmed Ali Mahmoud at 2 sites in Egypt.
Trial summary
1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination 2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- Norethisterone acetate
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Apr 2021to 25 Dec 2021
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: single arm single center study
Who may be able to join
- (1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia.
- regular menstrual cycles before administration of norethisterone; (4) no other treatment for adenomyosis/leiomyomatosis at least for 3 months biopsies and histopathology for operated patients;
Who cannot join
- (1) pregnant and/or breast-feeding women (2) patients with a ovarian neoplasm, benign ovarian cyst including endometrioma, pelvic inflammatory disease or other endocrine diseases.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ahmed Ali
Asyut
- Recruiting
Maternaty hospital in assiut
Asyut
About this study
Official title: Management of Uterine Leiomyomata and Adenomyosis : Role of Hysteroscopy in Diagnosis and Norethisterone in the Treatment
- to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
- to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma
Read the detailed description
The aim of the present study is:
- to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
- to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma
- Conditions
- Abnormal Uterine Bleeding
- Being tested
- Norethisterone acetate
- 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 for 5 months
| Study group | Role | What they receive |
|---|---|---|
| fibroid cases | Norethisterone acetate for 5 months Receives: Drug: Norethisterone acetate | |
| adenomyosis | Norethisterone acetate for 5 months Receives: Drug: Norethisterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis
Symptomatic improvement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start10 Apr 2021
- Primary completion25 Nov 2021
- Study completion25 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Ali Mahmoud
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Ahmed Ali Mahmoud, Assiut University
- Investigators
- Hisham Mo Taleb, Md, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153928
- Sponsor's protocol ID
- 12091984
- Status last verified
- Nov 2021
- First submitted
- 30 Nov 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wilde S, Scott-Barrett S. Radiological appearances of uterine fibroids. Indian J Radiol Imaging. 2009 Jul-Sep;19(3):222-31. doi: 10.4103/0971-3026.54887.
PubMed 19881092
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Uterine Leiomyomata and Adenomyosis : Role of Hysteroscopy in Diagnosis and Norethisterone in the Treatment
- ClinicalTrials.gov ID
- NCT05153928
- Acronym / sponsor ID
- 12091984
- Conditions
- Abnormal Uterine Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ahmed Ali MahmoudUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Dec 2021 (estimated)
- First posted
- 10 Dec 2021 (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.
- to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
- to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma
Detailed description
The aim of the present study is:
- to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
- to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fibroid cases | – | Drug: Norethisterone acetateNorethisterone acetate for 5 months |
| adenomyosis | – | Drug: Norethisterone acetateNorethisterone acetate for 5 months |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- single arm single center study
Key inclusion criteria (2 listed)
- (1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia.
- regular menstrual cycles before administration of norethisterone; (4) no other treatment for adenomyosis/leiomyomatosis at least for 3 months biopsies and histopathology for operated patients;
Key exclusion criteria (1 listed)
- (1) pregnant and/or breast-feeding women (2) patients with a ovarian neoplasm, benign ovarian cyst including endometrioma, pelvic inflammatory disease or other endocrine diseases.
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 for 5 months | Drug | adenomyosis, fibroid cases |
Primary outcome
is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis
Time frame: 6 months
Symptomatic improvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Background: PubMed 19881092Wilde S, Scott-Barrett S. Radiological appearances of uterine fibroids. Indian J Radiol Imaging. 2009 Jul-Sep;19(3):222-31. doi: 10.4103/0971-3026.54887.
- 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.
Hisham Mo Taleb, Md principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Uterine Bleeding, run by Ahmed Ali Mahmoud at 2 sites 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 1 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 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed Al Dr, Msc (00201003734246 ext. 002024745305, rcogahmedali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153928, which also lists 1 linked publication.
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 10 Dec 2021.