Heavy menstrual bleeding, dysmenorrhoea Heavy menstrual bleeding, dysmenorrhoea
Conditions
Interventions
Endometrial ablation and LNG-IUS combined, control group is standard care with 
only an endometrial ablation.
Sponsors
Máxima MC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Women suffering from heavy menstrual bleeding, who opt for treatment with EA, irrespective of the existence of fibroids, polyps or adenomyosis.
Exclusion criteria
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 with a (future) childwish - Women with a suspicion on endometrial cancer. - Women with contra-indications for levonorgestrel IUD. - Women with an already performed Endometrial Ablation. - Women over 60 years old.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: hysterectomy rate after 2 years of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction, PBAC-score, quality of life, cyclisch and non-cyclic pelvic pain, side-effects, re-interventions, complications and cost-effectiveness. | — |
Countries
Netherlands
Contacts
Public ContactTJ Oderkerk
Máxima MC
Outcome results
None listed