The objective of the study is to evaluate the global impression of improvement at 3 months following intramyometrial botulinum toxin injections via hysteroscopy in women with severe primary dysmenorrhea who have failed first-line medical treatment, compared to intramyometrial placebo injections.
Adult women who are not menopausal,
Experiencing severe dysmenorrhea, defined as an average pain intensity score ≥ 6/10 on a Numerical Rating Scale (NRS) over the past 3 months at the inclusion visit,
Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Level I and II analgesics, and NSAIDs),
Having undergone a pelvic MRI within 6 months prior to the inclusion visit that shows no evidence of deep infiltrating endometriosis or endometrioma, following systematic review by radiologists from the expert center managing the patient (if the pelvic MRI is deemed of insufficient quality for interpretation, a new MRI will be performed at the center),
Pregnant or planning a pregnancy during the entire study period,
Currently breastfeeding,
Refusal to use effective contraception during the study and for 6 months after its completion,
Generalized disorders of muscular activity (e.g., myasthenia gravis, Lambert-Eaton syndrome),
Nantes University Hospital
Lead sponsor
Merz Pharmaceuticals GmbH
Collaborator
Ministry of Health, France
Collaborator