Management of Uterine Leiomyomata and Adenomyosis
1 other identifier
observational
100
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2021
CompletedFirst Submitted
Initial submission to the registry
November 30, 2021
CompletedFirst Posted
Study publicly available on registry
December 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2021
CompletedDecember 10, 2021
November 1, 2021
8 months
November 30, 2021
November 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis
Symptomatic improvement
6 months
Study Arms (2)
fibroid cases
Norethisterone acetate for 5 months
adenomyosis
Norethisterone acetate for 5 months
Interventions
Eligibility Criteria
single arm single center study
You may qualify if:
- \- (1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia.
- (3) 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;
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ahmed Ali Mahmoudlead
- Assiut Universitycollaborator
Study Sites (2)
Ahmed Ali
Asyut, Egypt
Maternaty hospital in assiut
Asyut, Egypt
Related Publications (1)
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.
PMID: 19881092BACKGROUND
Biospecimen
Histopathological study
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hisham Mo Taleb, Md
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
November 30, 2021
First Posted
December 10, 2021
Study Start
April 10, 2021
Primary Completion
November 25, 2021
Study Completion
December 25, 2021
Last Updated
December 10, 2021
Record last verified: 2021-11