Management of Uterine Leiomyomata and Adenomyosis

Abnormal Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05153928
• Other study ID #: 12091984
• Status: Recruiting
• Start date: April 10, 2021
• Est. completion date: December 25, 2021

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: ahmed Al Dr, Msc
• Phone: 00201003734246
• Email: rcogahmedali[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 25, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Adenomyosis
• Leiomyoma
• Uterine Hemorrhage

Intervention

Drug:
• Norethisterone acetate
Norethisterone acetate for 5 months

Locations

Country	Name	City	State
Egypt	Ahmed Ali	Assiut
Egypt	Maternaty hospital in assiut	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Ahmed Ali Mahmoud	Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis	Symptomatic improvement	6 months