Ttt of Adenomyosis

Phase 1

Not yet recruiting

• Conditions: Adenomyosis
• Interventions: Drug: Dienogest 2 mg orally; Procedure: UAE

• Registration Number: NCT06719934
• Lead Sponsor: Al-Azhar University

Brief 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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Study Start: 2025-01-01
• Primary Completion: 2025-06-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dienogest group	Dienogest 2 mg orally	will take 2 mg oral Dienogest
Uterine artery embolization	UAE	will undergoes uterine artery embolization by local anasthesia

Primary Outcome Measures

Name	Time	Method
evaluation use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire	through study completion ,an average of 1 year	evaluation use of Dienogest versus uterine arteries embolization in improvement of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire

Trial Locations

Locations (1)

Al Azhar university; 🇪🇬 Assuit, Egypt