CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Severe primary dysmenorrhea

Inclusion criteria

• {"criterion_text":"- Adult women who are not menopausal\n- Experiencing severe dysmenorrhea, defined by an average pain intensity score of ≥ 6/10 on a Visual Analog Scale over the past 3 months at the inclusion visit\n- Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Step I and II, NSAIDs)\n- Having a pelvic MRI performed within 6 months prior to the inclusion visit, showing no evidence of deep pelvic endometriosis, endometriomas or myoma after systematic re-evaluation by the radiologists at the expert center managing the patient (if the pelvic MRI is deemed of insufficient quality for interpretation, it will be repeated at the center).\n- Using a highly effective contraception method (failure rate <1%) for the entire duration of the patient's follow-up. Highly effective contraception methods are defined as one of the following: combined hormonal contraception (containing estrogens and progestins) with ovulation inhibition (oral, intravaginal, transdermal), progestin-only hormonal contraception with ovulation inhibition (oral, injectable, implantable), intrauterine device (IUD), hormone-releasing intrauterine system (IUS), condoms, bilateral tubal occlusion, vasectomized partner, sexual abstinence.\n- Presenting with a negative blood pregnancy test at the inclusion visit and a negative urine test on the day of the procedure.\n- Having signed the informed consent for the study no later than Day 0"}

Exclusion criteria

• {"criterion_text":"- Pregnant patient or planning pregnancy throughout the duration of the study\n- Participation in another interventional clinical research trial\n- Having cooperation and/or understanding that does not allow strict adherence to the conditions outlined in the protocol\n- Being under a legal protective measure (guardianship, tutorship, judicial safeguard)\n- Patient presenting with deep pelvic endometriosis or a fibroid\n- Being on anticoagulant treatment between Month -1 and Month 1.\n- Infection or inflammation at the injection site\n- Postmenopausal woman (defined as at least 12 months of amenorrhea not related to hormonal treatment)\n- Not being affiliated with the French Social Security system\n- Not having the ability to connect to the internet to complete the questionnaires at M1 and M6\n- Unexpected discovery of an endocavitary lesion not previously diagnosed (polyp, fibroid, or uterine malformation) during the Day 0 visit.\n- Currently breastfeeding\n- Refusal to use highly effective contraception during the study and for the 6 months following the study\n- Having a contraindication to botulinum toxin: - Generalized muscle activity disorders (myasthenia, Lambert-Eaton syndrome), - Ongoing treatment with aminoglycosides, peripheral muscle relaxants, or amino-4-quinolines, - Hypersensitivity to the active substance, human albumin, or sucrose\n- Having coagulation disorders\n- Having an active vaginal or upper genital infection"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the response (favorable versus unfavorable) to the Patient Global Impression of Improvement (PGI-I) questionnaire at 3 months after the intra-myometrial injection. The response is considered favorable when the PGI-I score is 1 or 2.","definition_or_measurement_approach":"Measured using the Patient Global Impression of Improvement (PGI-I) questionnaire at 3 months post-injection; response defined as PGI-I score of 1 or 2."}

Secondary endpoints

• {"endpoint_text":"- Average and maximum intensity of dysmenorrhea evaluated using a Visual Analog Scale and duration (in days) during the last cycle before injection, then at 3 and 6 months.","definition_or_measurement_approach":"Average and maximum dysmenorrhea intensity measured via Visual Analog Scale (EVA) and duration in days assessed at baseline (last cycle before injection) and at 3 and 6 months."}
• {"endpoint_text":"- Average and maximum intensity of pelvic pain outside of menstruation, evaluated using a Visual Analog Scale before injection, then at 1, 3, and 6 months, and duration (in days).","definition_or_measurement_approach":"Pelvic pain intensity measured via Visual Analog Scale at baseline, 1, 3, and 6 months; duration in days recorded."}
• {"endpoint_text":"- Average and maximum intensity of pain during the last sexual intercourse, evaluated using a Visual Analog Scale before injection, then at 1, 3, and 6 months.","definition_or_measurement_approach":"Pain during last intercourse measured via Visual Analog Scale at baseline, 1, 3, and 6 months."}
• {"endpoint_text":"- Sexual function scale, Female Sexual Function Index (FSFI), evaluated before injection, then at 1, 3, and 6 months.","definition_or_measurement_approach":"Female Sexual Function Index (FSFI) questionnaire administered at baseline, 1, 3, and 6 months."}
• {"endpoint_text":"- Central sensitization pain score, Convergences PP, evaluated before injection, then at 3 months","definition_or_measurement_approach":"Central sensitization measured using the Convergences PP score at baseline and 3 months."}
• {"endpoint_text":"- Higham score for evaluating menstrual blood loss, assessed before injection, then at 3 and 6 months. Duration (in days) of menstruation during the last cycle evaluated before injection, then at 3 and 6 months.","definition_or_measurement_approach":"Menstrual blood loss assessed via Higham score at baseline, 3 and 6 months; menstruation duration in days recorded at same timepoints."}
• {"endpoint_text":"- Global quality of life score SF-36 and specific quality of life score EHP-5, evaluated before injection, then at 1, 3, and 6 months.","definition_or_measurement_approach":"Quality of life measured by SF-36 and EHP-5 questionnaires at baseline, 1, 3, and 6 months."}
• {"endpoint_text":"- Number of days of school or work absenteeism during the last month, assessed before injection, then at 1, 3, and 6 months","definition_or_measurement_approach":"Self-reported number of days absent from school or work during the last month at baseline, and at 1, 3, and 6 months."}
• {"endpoint_text":"- Anxiety score STAI-Y evaluated before injection and at 3 months. Depression score, Beck Depression Inventory (BDI-II), evaluated before injection and at 3 months.","definition_or_measurement_approach":"Anxiety measured by STAI-Y and depression by BDI-II at baseline and 3 months."}
• {"endpoint_text":"- Percentage of overall improvement (0-100%) evaluated at 1, 3, and 6 months. Patient Global Impression of Improvement (PGI-I) evaluated at 1 and 6 months. Patient’s willingness to undergo the intervention again (Yes/No) at 6 months and collection of justification.","definition_or_measurement_approach":"Overall improvement recorded as percentage (0-100%) at 1, 3, and 6 months; PGI-I at 1 and 6 months; willingness to repeat intervention (Yes/No) at 6 months with reason collected."}
• {"endpoint_text":"- Pain intensity experienced during the procedure and at 5 minutes, evaluated using a Visual Analog Scale","definition_or_measurement_approach":"Procedure pain intensity measured via Visual Analog Scale during procedure and at 5 minutes post-procedure."}
• {"endpoint_text":"- Adverse effects related to the injections collected in the immediate postoperative period, then at 1, 3, and 6 months","definition_or_measurement_approach":"Injection-related adverse events recorded in immediate postoperative period and at 1, 3, and 6 months."}
• {"endpoint_text":"- Occurrence of emergency consultations in the postoperative period, evaluated at 1 month","definition_or_measurement_approach":"Number/occurrence of postoperative emergency consultations assessed at 1 month."}
• {"endpoint_text":"- For the exploratory analysis of the MEOPA subgroup: primary endpoint, pain during the procedure, willingness to undergo the intervention again, adverse effects, and postoperative consultations","definition_or_measurement_approach":"Exploratory subgroup analysis in patients who received MEOPA evaluating primary endpoint and procedure-related outcomes as specified."}
• {"endpoint_text":"- For the exploratory analysis of the hormonal treatment subgroup: all primary and secondary endpoints","definition_or_measurement_approach":"Exploratory subgroup analysis in patients with prior hormonal treatment evaluating all primary and secondary endpoints."}

France

Earliest CTIS Part Ii Submission Date

09-05-2025

Latest Decision Or Authorization Date

19-09-2025

Processing Time Days

133

Number Of Sites

8

Number Of Participants

222

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France