Botulinum toxin type A injection in patients with chronic pelvic pain of uterine origin (severe dysmenorrhea and/or deep dyspareunia).Phase III, single-center, randomized study vs. control group - UTEROXINE

Centre de Recherche en Santé de la Femme0 个研究点目标入组 100 人开始时间: 2024年6月4日最近更新: 2024年6月10日

适应症

试验速览

暂无简介。

•- Be of age,
•- Present chronic pain of uterine origin VAS > 4 for at least 6 months,
•- These chronic pains of uterine origin can be due to severe dysmenorrhoea and/or deep dyspareunia and/or polycystic ovarian syndrome and/or fibroma and/or adenomyosis and/or superficial endometriosis, i.e. without involvement of organs other than gynaecological (e.g.: bladder, bowel, ureteral or more distant involvement)
•- To have been treated for these pains for at least 3 months, including at least a hormonal treatment and/or an analgesic treatment, or to have tried this treatment for at least 3 months, or to refuse this treatment, or intolerance, or contra-indication,
•- Be physically able to withstand a general anesthesia
•- To comply with the pre-anesthesia consultation before the operation
•- Have sufficient cooperation and understanding to comply with the requirements of the study,
•- Agree to give written consent,
•- Be affiliated with the French Social Security system.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Be a minor,
•- Have a contraindication to botulinum toxin: myasthenia, anticoagulant and antiplatelet agents, coagulation disorders, treatment with an aminoglycoside,
•- Hypersensitivity to the active substance or to human albumin or sucrose,
•- Have a contraindication to general anesthesia
•- Not to have attended the pre-anesthesia consultation
•- Pelvic ultrasound and/or laparoscopy and/or pelvic MRI showing deep endometriosis-type abnormalities except adenomyosis,
•- Have generalized muscle activity disorders (e.g. myasthenia gravis, Lambert-Eaton syndrome),
•- Have an infection or inflammation of the uterine wall,
•- Have active cervical cancer or any other history of malignancy within 5 years prior to inclusion, with the exception of non-melanoma skin cancer treated without evidence of recurrence.
•- Be pregnant or breastfeeding,
•- Participating in another clinical trial, or being in the exclusion period,
•- Have a level of cooperation and understanding that does not allow strict compliance with the conditions of the protocol,
•- To benefit from a legal protection measure (curatorship, guardianship...),
•- Not be affiliated to the French Social Security system.

发起方

Centre de Recherche en Santé de la Femme