NCT06719934

Ttt of Adenomyosis

Dienogest Versus Uterine Artery Embolization in Ttt of Adenomyosis -cohort Comparetive Study

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: Female
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

to evaluate use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms

Detailed description

Type of the study: prospective cohort comparative study. Setting: It will be done at both Obstetrics \& Gynecology department and Radiology department, Al-Azhar University Hospital Assiut branch. Time of the study: Starting from January 2025 till the end of the study Number of cases: 100 cases. According to sample size equation Where; in: n = number of patients, = 1.96 (standard normal deviate value that divides the central 95% of z distribution from 5% in the tails), P = the reported sensitivity (67%, i.e., 0.67), L= absolute precision desired on either side (half width of the confidence interval of the confidence interval) of sensitivity (10% i.e., 0.1). Inclusion criteria: * Age Group: 30-50 years * Women with adenomyosis * With or without small fibroids * Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms. Exclusion criteria: * Presence of a malignancy or pelvic infection. * An on-going pregnancy or a desire to conceive in the future. * Absolute contraindication for angiography (renal impairment). * Chronic debilitating diseases.

Conditions

• Adenomyosis

Interventions

Type	Name	Description
DRUG	Dienogest 2 mg orally	2 mg Dienogest orally
PROCEDURE	UAE	under local anasthesia uterine artery embolizationwill be done

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-01
• Completion: 2026-01-01
• First posted: 2024-12-06
• Last updated: 2024-12-06

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study