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NCT Number: NCT06719934

Ttt of Adenomyosis

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

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Key information

Conditions

Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Al Azhar university

Asyut, Assuit, 71524, Egypt

Location contact

Gamal mohammed Abd El Moez

CONTACT

[email protected]

201006704553+

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dienogest 2 mg orally

Drug

2 mg Dienogest orally

UAE

Procedure

under local anasthesia uterine artery embolizationwill be done

Primary outcomes

  1. 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

AL-Azhar university Assuit

CONTACT

[email protected]

0882148087

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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