Management of Uterine Leiomyomata and Adenomyosis

NCT ID: NCT05153928

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-10

Study Completion Date

2021-12-25

Brief Summary

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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

Detailed Description

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The aim of the present study is:

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

Conditions

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Abnormal Uterine Bleeding

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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fibroid cases

Norethisterone acetate for 5 months

Norethisterone acetate

Intervention Type DRUG

Norethisterone acetate for 5 months

adenomyosis

Norethisterone acetate for 5 months

Norethisterone acetate

Intervention Type DRUG

Norethisterone acetate for 5 months

Interventions

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Norethisterone acetate

Norethisterone acetate for 5 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- (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;

Exclusion Criteria

* (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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role collaborator

Ahmed Ali Mahmoud

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ali Mahmoud

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hisham Mo Taleb, Md

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Ahmed Ali

Asyut, , Egypt

Site Status RECRUITING

Maternaty hospital in assiut

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed Al Dr, Msc

Role: CONTACT

Phone: 00201003734246

Email: [email protected]

Ahmed Ali

Role: CONTACT

Phone: 00201003734246

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 19881092 (View on PubMed)

Other Identifiers

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12091984

Identifier Type: -

Identifier Source: org_study_id