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

NCT06995287 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

  • Primary Dysmenorrhea
  • Chronic Pelvic Pain

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.

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    collaborator INDUSTRY

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2028-06-09
Completion
2028-09-09

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06995287 on ClinicalTrials.gov