NCT06995287

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

Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the global impression of improvement at 3 months following intramyometrial botulinum toxin injections via hysteroscopy in women with severe primary dysmenorrhea who have failed first-line medical treatment, compared to intramyometrial placebo injections.

Detailed description

This trial is multicenter, placebo-controlled, randomized with center-based stratification, double-blind and prospective. The treatment consists of a single injection follow by 6 months of follow-up.

Conditions

• Primary Dysmenorrhea
• Chronic Pelvic Pain

Interventions

Type	Name	Description
DRUG	Xeomin	One injection will be performed via hysteroscopy under local anesthesia.
DRUG	Placebo	One injection will be performed via hysteroscopy under local anesthesia.

Timeline

• Start date: 2026-02-09
• Primary completion: 2028-06-09
• Completion: 2028-09-09
• First posted: 2025-05-29
• Last updated: 2026-02-12

Locations

8 sites across 1 country: France