Botulinum toxin type A injection in patients with chronic pelvic pain of uterine origin Phase III, single-center, randomized study vs. control group

Phase 1

• Conditions: PATIENTS WITH CHRONIC PELVIC PERINEAL PAIN OF UTERINE ORIGIN WITH VAS>4; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]; MedDRA version: 21.1Level: LLTClassification code 10011990Term: Deep dyspareuniaSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 21.1Level: LLTClassification code 10064189Term: Chronic pelvic pain syndromeSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.1Level: LLTClassification code 10013934Term: DysmenorrheaSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.0Level: LLTClassification code 10048581Term: Pelvic pain femaleSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 21.1Level: PTClassification code 10078087Term: Genito-pelvic pain/penetration disorderSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2020-006147-25-FR
• Lead Sponsor: Centre de Recherche en Santé de la Femme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-04
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified