This study is investigating a new treatment approach for severe primary dysmenorrhea, which is extremely painful menstrual periods without an identifiable underlying medical condition. The research focuses on intramyometrial botulinum toxin injections (injections into the muscle layer of the uterus) administered through hysteroscopy (a procedure that allows doctors to look inside the uterus) compared to placebo injections. The purpose is to evaluate whether this treatment can reduce pain in women who haven’t responded to standard treatments like hormonal therapy and pain medications.
The study is designed as a double-blind, randomized controlled trial, meaning neither the participants nor the researchers know who receives the actual treatment versus the placebo. Women participating in the study will undergo a procedure to receive either the botulinum toxin or placebo injections into their uterine muscle. They will then be followed for 6 months to assess changes in menstrual pain intensity, pain during intercourse, sexual function, quality of life, and other related symptoms.
Throughout the study, participants will complete various questionnaires about their pain levels, menstrual bleeding, quality of life, and overall impression of improvement. The main assessment will occur 3 months after the injection procedure to determine if participants experienced meaningful improvement in their symptoms.



France