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

Study acronym: HYSTEROXINE
StatusRecruiting
PhasePhase 3
Started2026-02-09
View on ClinicalTrials.gov ↗

Amendment history

2026-07-09
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations v2
Eligibility criteria+215 characters
Inclusion Criteria: Adult women who are not menopausal, ExperiencingPresenting with: Either severe primary dysmenorrhea, defined asby an average pain intensity score(VAS) ≥ 6/10 on a Numerical Rating Scale (NRS) over the pastlast 3 months at the inclusion visit, Or, in cases of amenorrhea under hormonal treatment, severe chronic pelvic pain (average VAS ≥ 6/10 over the last 3 months), described as cramp-like, localized in the pelvic region, and similar to the initial dysmenorrhea pain. Having failed optimal first-line medical treatment combining [...] algesics, and NSAIDs), Having undergone a pelvic [...]
Secondary endpoints30 to 67 entries
For the exploratory analysis of subgroups of patients with and without amenorrhea : Primary Outcome For the exploratory analysis of subgroups of patients with and without amenorrhea : Average intensity of dysmenorrhea For the exploratory analysis of subgroups of patients with and without amenorrhea [...] Exploratory analysis for the hormonal treatment subgroup : WillingnessAverage intensity of dysmenorrhea Exploratory analysis for the hormonal treatment subgroup : Maximum intensity of dysmenorrhea Exploratory analysis for the hormonal treatment subgroup : Duration of dysmenorrhea Exploratory analysi [...] [...]
Study sitesdetails revised at 6 of 8 sites
Study title+11 characters
Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in SeverePelvic PrimaryPain Suggestive of Dysmenorrhea
2026-02-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-09-01→2028-06-09
Completion date2028-01-01→2028-09-09
Start dateestimated 2025-06-01→confirmed 2026-02-09
Study sitesdetails revised at 8 of 8 sites
2025-05-20
Original filing
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.
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