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),
Parallel
Xeomin
DrugOne injection will be performed via hysteroscopy under local anesthesia.
Placebo
DrugOne injection will be performed via hysteroscopy under local anesthesia.
Patient Global Improvement
The response (favorable versus unfavorable) to the Patient Global Impression of Improvement questionnaire at 3 months following intra-myometrial injection. A response is considered favorable when the score of Patient Global Impression of Improvement questionnaire is 1 or 2. Patient Global Impression of Improvement questionnaire is self-assessment scale ranging from 1 (Very much improved) to 7 (Very much worsened).
Average intensity of dysmenorrhea
Average intensity of dysmenorrhea evaluated using a numerical rating scale during the last menstrual cycle before injection, then at 3 and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Maximum intensity of dysmenorrhea
Maximum intensity of dysmenorrhea evaluated using a numerical rating scale during the last menstrual cycle before injection, then at 3 and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Duration of dysmenorrhea
Duration (in days) of dysmenorrhea during the last menstrual cycle before injection, then at 3 and 6 months.
Average intensity of non-menstrual pelvic pain
Average intensity of non-menstrual pelvic pain evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
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Nantes University Hospital
Lead sponsor
Merz Pharmaceuticals GmbH
Collaborator
Ministry of Health, France
Collaborator
