Study of Intramyometrial Botulinum Toxin Injection by Hysteroscopy for Severe Pelvic Pain and Dysmenorrhea in Adult Women Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with 6-Month Follow-Up

What this Trial Is About

This trial studies women with severe primary dysmenorrhea or chronic pelvic pain related to dysmenorrhea who have not improved with first-line medical treatments. The purpose is to compare the effects of a botulinum toxin injection versus a placebo injection given directly into the uterine muscle through hysteroscopy. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate pain improvement at three months post-treatment. Participants will receive a single injection of either botulinum toxin type A Xeomin or a placebo via hysteroscopy under local anesthesia. Following the injection, they will be followed for six months. Follow-up includes remote completion of questionnaires at one and six months, and an in-person consultation at three months to assess outcomes and complete additional questionnaires. During the study, participants will complete various evaluations including pain intensity, sexual function, quality of life, anxiety, and depression assessments at multiple time points up to six months. Safety monitoring includes recording adverse events and emergency visits related to the injections. The main outcome is the patients global impression of improvement at three months. The total participation period lasts six months with scheduled follow-ups to monitor treatment effects and safety.

Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea