RecruitingPhase 3NCT06995287

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

Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea: A Prospective, Multicenter, Double-Blind, Randomized Placebo-Controlled Study.


Sponsor

Nantes University Hospital

Enrollment

222 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Xeomin for people with chronic pelvic pain and primary dysmenorrhea. The study is currently recruiting participants at 8 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXeomin

One injection will be performed via hysteroscopy under local anesthesia.

DRUGPlacebo

One injection will be performed via hysteroscopy under local anesthesia.


Locations(8)

Clinique axium / Centre resilience

Aix-en-Provence, France

CHU Angers

Angers, France

CHU Brest

Brest, France

CHU Lille

Lille, France

Hôpital de la Croix-Rousse

Lyon, France

CHU Nantes

Nantes, France

Clinique Brétéché

Nantes, France

CHU Rennes

Rennes, France

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NCT06995287


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