A randomised controlled trial comparing endometrial ablation plus levonorgestrel releasing intrauterine system versus endometrial ablation alone in women with heavy menstrual bleeding.
Recruiting
- Conditions
- Heavy menstrual bleedingDysmenorroea
- Registration Number
- NL-OMON25628
- Lead Sponsor
- Máxima Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 718
Inclusion Criteria
Women suffering from heavy menstrual bleeding, who do not wish or benefit from another treatment for heavy menstrual bleeding (medication or LNG-IUS) and opt for treatment with EA, irrespective of the existence of fibroids, polyps or adenomyosis. Earlier use of LNG-IUS is no exclusion.
Exclusion Criteria
•Women who don’t speak Dutch or English to a standard that they can fully understand the study and complete the trial questionnaires.
•Women who might want to get pregnant in the future will not be included since an endometrium ablation interferes with future pregnancies.
•Suspicion on endometrial cancer.
•Contra-indications for levonorgestrel IUD.
•Already performed Eandometrial Ablation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hysterectomy rate after 2 years of follow-up.
- Secondary Outcome Measures
Name Time Method Patient satisfaction, PBAC-score, quality of life, cyclic and non-cyclic pelvic pain, re-interventions, complications, side-effects and cost-effectiveness.