Clinical Trial

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

Study acronym: HYSTEROXINE
Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-20; most recent amendment 2026-07-09.
Status change: Not Yet Recruiting → Recruiting 2026-02-09
Trial Details
NCT Number NCT06995287
Lead Sponsor Nantes University Hospital
Collaborators: Merz Pharmaceuticals GmbH, Ministry of Health, France
Conditions Primary Dysmenorrhea, Chronic Pelvic Pain
Enrollment 222 participants
Start Date 2026-02-09
Primary Completion 2028-06-09 (estimated)
Study Completion 2028-09-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-13