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RECRUITING
NCT06995287
PHASE3

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2026-02-09

Completion Date

2028-09-09

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DRUG

Xeomin

One injection will be performed via hysteroscopy under local anesthesia.

DRUG

Placebo

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