Ttt of Adenomyosis

NCT ID: NCT06719934

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-01-01

Brief Summary

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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

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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

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Adenomyosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Dienogest group

will take 2 mg oral Dienogest

Group Type EXPERIMENTAL

Dienogest 2 mg orally

Intervention Type DRUG

2 mg Dienogest orally

Uterine artery embolization

will undergoes uterine artery embolization by local anasthesia

Group Type EXPERIMENTAL

UAE

Intervention Type PROCEDURE

under local anasthesia uterine artery embolizationwill be done

Interventions

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Dienogest 2 mg orally

2 mg Dienogest orally

Intervention Type DRUG

UAE

under local anasthesia uterine artery embolizationwill be done

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Eshraq Arabi

Assuit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Azhar university

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

Central Contacts

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AL-Azhar university Assuit

Role: CONTACT

Phone: 0882148087

Email: [email protected]

Facility Contacts

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Gamal mohammed Abd El Moez

Role: primary

Other Identifiers

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121212121212121212121212121212

Identifier Type: -

Identifier Source: org_study_id