Ttt of Adenomyosis

Al-Azhar University

Status and phase: Not yet enrolling; Phase 1

Conditions: Adenomyosis

Treatments: Procedure: UAE; Drug: Dienogest 2 mg orally

Study type: Interventional

Funder types: Other

Identifiers

NCT06719934

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Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Dienogest group

Experimental group

Description:

will take 2 mg oral Dienogest

Treatment:

Drug: Dienogest 2 mg orally

Uterine artery embolization

Experimental group

Description:

will undergoes uterine artery embolization by local anasthesia

Treatment:

Procedure: UAE