Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
ADENOTREAT
1 other identifier
interventional
230
1 country
4
Brief Summary
The present study aims to compare the efficacy (menstrual blood loss, pain, quality of life) and the safety (complications, recovery) of each conservative intervention (RFA, UAE) versus hysterectomy for the treatment of adenomyosis-related abnormal uterine bleeding, up to 2 years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2025
CompletedFirst Posted
Study publicly available on registry
September 26, 2025
CompletedStudy Start
First participant enrolled
April 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
April 20, 2026
April 1, 2026
3 years
August 18, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of 2-year clinical success of the intervention
proportion of 2-year clinical success of the intervention, defined as a significant reduction in menstrual blood loss (Pictorial Blood Assessment Chart-PBAC, score \<100). Women undergoing RFA or UAE and requiring subsequent hysterectomy for persistent AUB before 2 years will be considered as clinical failure.
Year 2
Secondary Outcomes (22)
Proportion clinical success of the intervention
Month 1, Month 5, Year 1
Proportion in self-reported amenorrhea
Month 1, Month 5, Year 1, Year 2
Mean changes in severity of dysmenorrhea between UAE and RFA
Year 2
Mean changes in pelvic pain
Year 2
Mean changes in deep dyspareunia
Year 2
- +17 more secondary outcomes
Study Arms (3)
Radiofrequency endometrial ablation
EXPERIMENTALRadiofrequency endometrial ablation performed using NovaSure®
Uterine artery embolization
EXPERIMENTALUterine artery embolization carried out under the guidance of digital subtraction angiography
Hysterectomy
ACTIVE COMPARATORHysterectomy
Interventions
Radiofrequency endometrial ablation
Eligibility Criteria
You may qualify if:
- Premenopausal women aged 30 to 50 years
- Women who had at least 3 prior months failed medical therapy, or a contraindication to medical therapy, or refused medical therapy for adenomyosis-related AUB
- Symptomatic pure internal adenomyosis or dominant adenomyosis (with less than 5 concurrent uterine fibroids type 3-7 \< 5 cm) confirmed by MRI (\< 6 months) according to ESHRE criteria
- AUB defined as a PBAC score \>100 at baseline
- Uterine ultrasound measurement of 6.0-12.0 cm (external os to internal fundus)
- Women with an indication for hysterectomy for adenomyosis-related AUB and accepting hysterectomy
- Highly effective contraception for women of childbearing potential, maintained until the onset of menopause
- Affiliated or beneficiary of health insurance
- Signed informed consent
You may not qualify if:
- Uterine cavity abnormality or obstruction confirmed via imaging modalities or hysteroscopy
- Deep infiltrating posterior subperitoneal endometriosis involving contiguous digestive tract structures
- Uterine malignancy within the last five years
- Secreting ovarian tumor
- Atypical endometrial hyperplasia
- Unaddressed high grade cervical intra-epithelial lesions
- Active sexually transmitted disease or pelvic inflammatory disease
- Documented or suspected coagulopathies or long-term blood-thinner medications
- Prior transmural myomectomy or prior endometrial ablation
- Plasma FSH level \> 40 IU/mL
- Any contraindication to angiography (including iodine allergy and creatinine clearance \< 60mL/min)
- Any contraindication to MRI (claustrophobia, pace maker, etc.)
- Any contraindication to the use of Embosphere®, Embozene® or NovaSure® according to the instruction for use
- Women who are pregnant, breastfeeding, or who are planning to become pregnant
- Any condition or any situation that would prohibit women from coming to the investigational center for the 6 months follow-up
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU Bordeaux
Bordeaux, France
APHP - Hôpital Antoine Béclère
Clamart, 92140, France
CHU Limoges
Limoges, 87042, France
CHU Montpellier
Montpellier, 34090, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2025
First Posted
September 26, 2025
Study Start
April 17, 2026
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share