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,
Either severe primary dysmenorrhea, defined by an average pain intensity (VAS) ≥ 6/10 over the last 3 months at the inclusion visit,
Or, in cases of amenorrhea under hormonal treatment, severe chronic pelvic pain (average VAS ≥ 6/10 over the last 3 months), described as cramp-like, localized in the pelvic region, and similar to the initial dysmenorrhea pain.
Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Level I and II analgesics, and NSAIDs),
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