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New treatment option for Abnormal Uterine Bleeding Due to Adenomyosis (Disorder)
Official title Radiofrequency Endometrial Ablation or Uterine Artery Embolization for Treatment of Adenomyosis-related Abnormal Uterine Bleeding
ClinicalTrials.gov ID: NCT07195305
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 50, women only
You may be able to join 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...
- Symptomatic pure internal adenomyosis or dominant adenomyosis (with less than 5 concurrent uterine fibroids type 3-7 \< 5 cm) confirmed by MRI (\< 6...
- AUB defined as a PBAC score \>100 at baseline
- Uterine ultrasound measurement of 6.0-12.0 cm (external os to internal fundus)
You likely can't join 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
See the full eligibility criteria
- 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
- 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
- Women unable to understand the nature, risks, significance and implications of the clinical investigation
- Women under legal protection
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Clamart, France
- Limoges, France
- Montpellier, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 30 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Clamart, France; Limoges, France; Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.