Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea

Launched by NANTES UNIVERSITY HOSPITAL · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of injecting a substance called botulinum toxin (commonly known for its use in cosmetic treatments) into the uterus to help relieve severe menstrual pain, known as primary dysmenorrhea. The study aims to see if this treatment can improve pain levels for women who have tried other medications without success. Women who are eligible to participate are adult females who are not menopausal, experience significant menstrual pain, have not found relief from standard treatments, and have undergone specific medical imaging to rule out other conditions.

Participants in the trial will receive either the botulinum toxin injection or a placebo (a substance with no active medication) through a procedure called hysteroscopy. This trial will track their pain levels and overall improvement over a three-month period. It’s important to note that participants will need to use effective contraception during the study and have some medical checks before beginning. This study is not currently recruiting, but it aims to provide valuable information about a new potential treatment for chronic pelvic pain in women.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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),
• • Using a highly effective method of contraception (failure rate \<1%) for the entire duration of the follow-up period. Highly effective contraception methods are defined as one of the following: combined hormonal contraception (containing estrogen and progestin) with ovulation inhibition (oral, vaginal, or transdermal), progestin-only hormonal contraception with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormonal system (IUS), condoms, bilateral tubal occlusion, vasectomized partner, or sexual abstinence,
• • Having a negative urine pregnancy test on the day of the procedure,
• • Having signed the informed consent form for the study at the M-1 visit.
• Exclusion Criteria:
• • 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,
• * Contraindications to botulinum toxin, including:
• • Generalized disorders of muscular activity (e.g., myasthenia gravis, Lambert-Eaton syndrome),
• • Ongoing treatment with aminoglycosides, peripheral muscle relaxants, or amino-4-quinolines,
• • Hypersensitivity to the active substance, human albumin, or sucrose,
• • Bleeding disorders or current treatment with anticoagulants,
• • Ongoing vaginal or upper genital tract infection,
• • Participation in another interventional clinical trial,
• • Inability to cooperate or understand the study requirements in a way that would allow strict adherence to the protocol,
• • Subject to legal protection measures (e.g., guardianship, curatorship, or judicial protection),
• • Not affiliated with the French social security system,
• • Unable to access the internet to complete questionnaires at Month 1 and Month 6.