Abnormal Uterine Bleeding Due to Adenomyosis (Disorder)ADENOTREATNCT07195305
Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
A study testing Radiofrequency endometrial ablation, Uterine artery embolization and Hysterectomy in people with Abnormal Uterine Bleeding Due to Adenomyosis (Disorder), run by University Hospital, Bordeaux at 4 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding Due to Adenomyosis (Disorder)
- What is being tested?
- Radiofrequency endometrial ablation, Uterine artery embolization and Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 4 sitesFrance
- Study dates
- 17 Apr 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Highly effective contraception for women of childbearing potential, maintained until the onset of menopause
- Affiliated or beneficiary of health insurance
- Signed informed consent
Who cannot join
- 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
Show all 17Show fewer
- 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
- Women unable to understand the nature, risks, significance and implications of the clinical investigation
- Women under legal protection
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
CHU Bordeaux
Bordeaux
Jean-Luc BRUN, MD, PhD, +33 5 56 79 59 85, jean-luc.brun@chu-bordeaux.fr
- Not yet recruiting
APHP - Hôpital Antoine Béclère
Clamart, 92140
Xavier DEFFIEUX, xavier.deffieux@aphp.fr
- Not yet recruiting
CHU Limoges
Limoges, 87042
Tristan GAUTHIER, tristan.gauthier@chu-limoges.fr
- Recruiting
CHU Montpellier
Montpellier, 34090
Martha DURAES, m-duraes@chu-montpellier.fr
About this study
Official title: Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Women With Adenomyosis-related Abnormal Uterine Bleeding Eligible for Hysterectomy: a Non-inferiority Randomized Clinical Trial Comparing Each Intervention to Hysterectomy
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
Read the detailed description
Adenomyosis is defined by the presence of ectopic non-atypical endometrial glands and stroma within the smooth muscle fibers of the myometrium causing reactive hypertrophy of the uterus. The prevalence of adenomyosis is approximately 20% before 40 years, and probably higher in the following decade. One-third of women with adenomyosis are symptomatic. Symptoms include abnormal uterine bleeding (AUB) (40-50%), pelvic pain (dysmenorrhea 15-30%, dyspareunia) and are related to the uniformly enlarged and globular uterus (distension, swelling). Adenomyosis can be diagnosed by transvaginal ultrasonography and/or magnetic resonance imaging (MRI). Symptoms associated with adenomyosis can be treated by hormonal or non-hormonal medications. When medical treatment fails, a hysterectomy is proposed to women who do not consider childbearing. For women who wish to preserve their uterus, two alternatives are possible.
Radiofrequency ablation (RFA) is intended to ablate the endometrial lining of the uterus on pre-menopausal women with AUB due to benign causes for whom childbearing is complete. This outpatient procedure is well tolerated, with 10% of post-operative adverse events within one year, mainly not serious like pelvic pain/cramping and vaginal discharge/infection.
Uterine artery embolization (UAE) is as a minimally invasive treatment for symptomatic uterine fibroids since 1995. This procedure is also well tolerated, with efficacy and satisfaction rates of 85% at 2 years, performed usually as a day case or with a short hospital stay of 12-24h to manage immediate post-operative pain.
Therefore the extension of the indications of both techniques in AUB associated with adenomyosis should be questioned.
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
- Being tested
- Radiofrequency endometrial ablation, Uterine artery embolization, Hysterectomy
- Keywords
- Radiofrequency endometrial ablation, Uterine artery embolization, Hysterectomy, Adenomyosis, Abnormal uterine bleeding
- Medical subject headings
- Adenomyosis, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency endometrial ablationProcedure or surgery
Radiofrequency endometrial ablation
Uterine artery embolizationProcedure or surgery
Uterine artery embolization
HysterectomyProcedure or surgery
Hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency endometrial ablation | Experimental | Radiofrequency endometrial ablation performed using NovaSure® Receives: Procedure: Radiofrequency endometrial ablation |
| Uterine artery embolization | Experimental | Uterine artery embolization carried out under the guidance of digital subtraction angiography Receives: Procedure: Uterine artery embolization |
| Hysterectomy | Active comparator | Hysterectomy Receives: Procedure: Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 2
Secondary outcomes (22)
Proportion clinical success of the intervention
Proportion clinical success of the intervention, defined as a significant reduction in menstrual blood loss (PBAC score <100)
Measured: Month 1, Month 5, Year 1
Proportion in self-reported amenorrhea
Proportion in self-reported amenorrhea (PBAC score = 0),
Measured: Month 1, Month 5, Year 1, Year 2
Mean changes in severity of dysmenorrhea between UAE and RFA
Mean changes in severity of dysmenorrhea between Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA) (visual analogue scale rating from 0 to 10),
Measured: Year 2
Mean changes in pelvic pain
Mean changes in pelvic pain (visual analogue scale rating from 0-no pain to 10-extreme pain);
Measured: Year 2
Mean changes in deep dyspareunia
Mean changes in deep dyspareunia (visual analogue scale rating from 0-no pain to 10-extreme pain);
Measured: Year 2
Mean changes in pelvic distension
Mean changes in pelvic distension (visual analogue scale rating from 0-no pain to 10-extreme pain);
Measured: Year 2
Mean duration of hospital stay
Mean duration of hospital stay (in days);
Measured: Hospital discharge
Mean time to return to normal life
Mean time to return to normal life (in days);
Measured: Month 1
Mean change in quality of life
Mean change in quality of life assessed using UFS-QoL questionnaire (Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire, from 29 poins (best health-related quality of life to 145 (worse health-related quality of life)
Measured: Year 2
Mean change in endometriosis quality of life
Mean change in endometriosis quality of life assessed using EHP-5 questionnaire (Short form endometriosis health profile, from 0 (best possible state of health) to 100 (worst possible state of health)
Measured: Year 2
Mean change in sexual life quality
Mean change in sexual life quality using FSFI questionnaire (Female Sexual Function Index from 2 (worse sexual life quality to 36 (best sexual life quality; 26.55 indicating the lower score reflecting the existence of sexual disorders
Measured: Year 2
Mean satisfaction with the intervention
Mean satisfaction with the intervention (7-point Likert scale) from hospital discharge to 2 years;
Measured: Year 2
Proportion of women with correction of iron-deficiency anemia
Proportion of women with correction of iron-deficiency anemia, if diagnosed at baseline
Measured: Year 2
Rate and severity of intra-operative complications
Rate and severity of intra-operative complications (according to Clavien Dindo classification)
Measured: Hospital discharge
Severity of intra-operative complications
Severity of intra-operative complications (according to Clavien Dindo classification)
Measured: Hospital discharge
Analgesic and/or non-steroidal anti-inflammatory drug intake
Analgesic and/or non-steroidal anti-inflammatory drug intake (type, daily dose, duration)
Measured: Week 1
Rate of post-operative adverse events
Rate of post-operative adverse events
Measured: Year 2
Severity of post-operative adverse events
Severity of post-operative adverse events
Measured: Year 2
Mean change in junctional zone thickness
Mean change in MRI junctional zone thickness accordingly to European Society of Human Reproduction and Embryology-ESHRE- criteria bewteen Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA
Measured: Month 6
Mean change in percentage of necrosis
Mean change in MRI percentage of necrosis accordingly to European Society of Human Reproduction and Embryology-ESHRE- criteria bewteen Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA
Measured: Month 6
Mean change in uterine vascularization
Mean change in MRI uterine vascularization accordingly to European Society of Human Reproduction and Embryology-ESHRE- criteria bewteen Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA
Measured: Month 6
Mean change of hormonal parameters
Mean change of hormonal parameters (FH, estradiol), if post-operative amenorrhea occurred after Uterine Artery Embolisation-UAE and Radiofrequency endometrial ablation-RFA
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start17 Apr 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine Bleeding Due to Adenomyosis (Disorder)Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195305
- Sponsor's protocol ID
- CHUBX 2024/47
- Acronym
- ADENOTREAT
- Status last verified
- Apr 2026
- First submitted
- 18 Aug 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Women With Adenomyosis-related Abnormal Uterine Bleeding Eligible for Hysterectomy: a Non-inferiority Randomized Clinical Trial Comparing Each Intervention to Hysterectomy
- ClinicalTrials.gov ID
- NCT07195305
- Acronym / sponsor ID
- ADENOTREAT / CHUBX 2024/47
- Keywords
- Radiofrequency endometrial ablation, Uterine artery embolization, Hysterectomy, Adenomyosis, Abnormal uterine bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Adenomyosis is defined by the presence of ectopic non-atypical endometrial glands and stroma within the smooth muscle fibers of the myometrium causing reactive hypertrophy of the uterus. The prevalence of adenomyosis is approximately 20% before 40 years, and probably higher in the following decade. One-third of women with adenomyosis are symptomatic. Symptoms include abnormal uterine bleeding (AUB) (40-50%), pelvic pain (dysmenorrhea 15-30%, dyspareunia) and are related to the uniformly enlarged and globular uterus (distension, swelling). Adenomyosis can be diagnosed by transvaginal ultrasonography and/or magnetic resonance imaging (MRI). Symptoms associated with adenomyosis can be treated by hormonal or non-hormonal medications. When medical treatment fails, a hysterectomy is proposed to women who do not consider childbearing. For women who wish to preserve their uterus, two alternatives are possible.
Radiofrequency ablation (RFA) is intended to ablate the endometrial lining of the uterus on pre-menopausal women with AUB due to benign causes for whom childbearing is complete. This outpatient procedure is well tolerated, with 10% of post-operative adverse events within one year, mainly not serious like pelvic pain/cramping and vaginal discharge/infection.
Uterine artery embolization (UAE) is as a minimally invasive treatment for symptomatic uterine fibroids since 1995. This procedure is also well tolerated, with efficacy and satisfaction rates of 85% at 2 years, performed usually as a day case or with a short hospital stay of 12-24h to manage immediate post-operative pain.
Therefore the extension of the indications of both techniques in AUB associated with adenomyosis should be questioned.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency endometrial ablation | Experimental | Procedure: Radiofrequency endometrial ablationRadiofrequency endometrial ablation performed using NovaSure® |
| Uterine artery embolization | Experimental | Procedure: Uterine artery embolizationUterine artery embolization carried out under the guidance of digital subtraction angiography |
| Hysterectomy | Active comparator | Procedure: HysterectomyHysterectomy |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency endometrial ablationRadiofrequency endometrial ablation | Procedure or surgery | Radiofrequency endometrial ablation |
| Uterine artery embolizationUterine artery embolization | Procedure or surgery | Uterine artery embolization |
| HysterectomyHysterectomy | Procedure or surgery | Hysterectomy |
Primary outcome
proportion of 2-year clinical success of the intervention
Time frame: Year 2
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.
22 secondary outcomes
Proportion clinical success of the intervention
Time frame: Month 1, Month 5, Year 1
Proportion in self-reported amenorrhea
Time frame: Month 1, Month 5, Year 1, Year 2
Mean changes in severity of dysmenorrhea between UAE and RFA
Time frame: Year 2
Mean changes in pelvic pain
Time frame: Year 2
Mean changes in deep dyspareunia
Time frame: Year 2
Mean changes in pelvic distension
Time frame: Year 2
Mean duration of hospital stay
Time frame: Hospital discharge
Mean time to return to normal life
Time frame: Month 1
Mean change in quality of life
Time frame: Year 2
Mean change in endometriosis quality of life
Time frame: Year 2
Mean change in sexual life quality
Time frame: Year 2
Mean satisfaction with the intervention
Time frame: Year 2
Proportion of women with correction of iron-deficiency anemia
Time frame: Year 2
Rate and severity of intra-operative complications
Time frame: Hospital discharge
Severity of intra-operative complications
Time frame: Hospital discharge
Analgesic and/or non-steroidal anti-inflammatory drug intake
Time frame: Week 1
Rate of post-operative adverse events
Time frame: Year 2
Severity of post-operative adverse events
Time frame: Year 2
Mean change in junctional zone thickness
Time frame: Month 6
Mean change in percentage of necrosis
Time frame: Month 6
Mean change in uterine vascularization
Time frame: Month 6
Mean change of hormonal parameters
Time frame: Year 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency endometrial ablation, Uterine artery embolization and Hysterectomy in people with Abnormal Uterine Bleeding Due to Adenomyosis (Disorder), run by University Hospital, Bordeaux at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Luc Brun, MD, PhD (+33 5 56 79 59 85, jean-luc.brun@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of 2-year clinical success of the intervention (time frame: Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.