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Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea
Sponsor: Nantes University Hospital
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
Conditions
Interventions
Xeomin
One injection will be performed via hysteroscopy under local anesthesia.
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