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

Sponsor
Nantes University Hospital
Study ID
NCT06995287
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Pelvic Pain
  • Primary Dysmenorrhea

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xeomin — DRUG
    One injection will be performed via hysteroscopy under local anesthesia.
  • Placebo — DRUG
    One injection will be performed via hysteroscopy under local anesthesia.

Study Details

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.

Key Dates

First listed
May 29, 2025
Start date
Feb 9, 2026
Status verified
Jul 2026
Primary completion
Jun 9, 2028
Completion
Sep 9, 2028

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Botulinum toxin type A
    One injection will be performed via hysteroscopy under local anesthesia. The patient will be followed up remotely at M1 and M6 to complete questionnaires, and will be seen in site at M3 for a postoperative consultation and to complete questionnaires.
  • Placebo Comparator: Placebo
    One injection will be performed via hysteroscopy under local anesthesia. The patient will be followed up remotely at M1 and M6 to complete questionnaires, and will be seen in site at M3 for a postoperative consultation and to complete questionnaires.

Primary Outcome Measure

Patient Global Improvement [ Time Frame: 3 months ]

Central Contacts

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