Management of Uterine Leiomyomata and Adenomyosis

Sponsor

Ahmed Ali Mahmoud (Other)

Overall Status

Recruiting

CT.gov ID

NCT05153928

Collaborator

Assiut University (Other)

100

Enrollment

Locations

8.5

Anticipated Duration (Months)

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Abnormal Uterine Bleeding	Drug: Norethisterone acetate

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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

Management of Uterine Leiomyomata and Adenomyosis : Role of Hysteroscopy in Diagnosis and Norethisterone in the Treatment

Actual Study Start Date :

Apr 10, 2021

Actual Primary Completion Date :

Nov 25, 2021

Anticipated Study Completion Date :

Dec 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
fibroid cases Norethisterone acetate for 5 months	Drug: Norethisterone acetate Norethisterone acetate for 5 months
adenomyosis Norethisterone acetate for 5 months	Drug: Norethisterone acetate Norethisterone acetate for 5 months

Arm

Intervention/Treatment

fibroid cases

Norethisterone acetate for 5 months

Drug: Norethisterone acetate

Norethisterone acetate for 5 months

adenomyosis

Norethisterone acetate for 5 months

Drug: Norethisterone acetate

Norethisterone acetate for 5 months

Outcome Measures

Primary Outcome Measures

is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis [6 months]
Symptomatic improvement

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.