NCT06719934

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 6, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 27, 2024

Last Update Submit

December 2, 2024

Conditions

Adenomyosis

Outcome Measures

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

    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

    through study completion ,an average of 1 year

Study Arms (2)

Dienogest group

EXPERIMENTAL

will take 2 mg oral Dienogest

Drug: Dienogest 2 mg orally

Uterine artery embolization

EXPERIMENTAL

will undergoes uterine artery embolization by local anasthesia

Procedure: UAE

Interventions

Dienogest 2 mg orallyDRUG

2 mg Dienogest orally

Dienogest group
UAEPROCEDURE

under local anasthesia uterine artery embolizationwill be done

Uterine artery embolization

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with adenomyosis
  • With or without small fibroids
  • Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar university

Asyut, Assuit, 71524, Egypt

Location

MeSH Terms

Conditions

Adenomyosis

Interventions

dienogest

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

AL-Azhar university Assuit

CONTACT

0882148087Eshrq.arabi2020@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assuit

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 6, 2024

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion

January 1, 2026

Last Updated

December 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)