Botulinum toxin injected into the uterine muscle to reduce severe menstrual pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial comparing a single intramyometrial injection of botulinum toxin (Xeomin) delivered by hysteroscopy versus a placebo injection in women with severe primary dysmenorrhea. Participants must be premenopausal adult women with an average pain score of at least 6/10 who have failed optimized first-line therapy and have pelvic MRI excluding deep infiltrating endometriosis. Randomization is stratified by center and participants are followed for six months, with the primary outcome being global impression of improvement at three months. The design includes blinded outcome assessment to compare analgesic effect and safety between active treatment and placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult women who are not menopausal,
* Presenting with:
* Either severe primary dysmenorrhea, defined by an average pain intensity (VAS) ≥ 6/10 over the last 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 hormonal therapy and appropriate analgesics (Level I and II analgesics, and NSAIDs),
* Having undergone a pelvic MRI within 1 year prior to the randomization visit that shows no evidence of deep infiltrating endometriosis or endometrioma, following systematic review by radiologists from the expert center managing the patient (if the pelvic MRI is deemed of insufficient quality for interpretation, a new MRI will be performed at the center),
* Using a highly effective method of contraception (failure rate \<1%) for the entire duration of the follow-up period. Highly effective contraception methods are defined as one of the following: combined hormonal contraception (containing estrogen and progestin) with ovulation inhibition (oral, vaginal, or transdermal), progestin-only hormonal contraception with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormonal system (IUS), condoms, bilateral tubal occlusion, vasectomized partner, or sexual abstinence,
* Having a negative urine pregnancy test on the day of the procedure,
* Having signed the informed consent form for the study at the M-1 visit.

Exclusion Criteria:

* Pregnant or planning a pregnancy during the entire study period,
* Currently breastfeeding,
* Refusal to use effective contraception during the study and for 6 months after its completion,
* Contraindications to botulinum toxin, including:
* Generalized disorders of muscular activity (e.g., myasthenia gravis, Lambert-Eaton syndrome),
* Ongoing treatment with aminoglycosides, peripheral muscle relaxants, or amino-4-quinolines,
* Hypersensitivity to the active substance, human albumin, or sucrose,
* Bleeding disorders or current treatment with anticoagulants,
* Ongoing vaginal or upper genital tract infection,
* Participation in another interventional clinical trial,
* Inability to cooperate or understand the study requirements in a way that would allow strict adherence to the protocol,
* Subject to legal protection measures (e.g., guardianship, curatorship, or judicial protection),
* Not affiliated with the French social security system,
* Unable to access the internet to complete questionnaires at Month 1 and Month 6.

Where it's running

• Clinique axium / Centre resilience
  Aix-en-Provence, France Recruiting
• CHU Angers
  Angers, France Recruiting
• CHU Brest
  Brest, France Recruiting
• CHU Lille
  Lille, France Recruiting
• Hôpital de la Croix-Rousse
  Lyon, France Recruiting
• CHU Nantes
  Nantes, France Recruiting

Study contacts

• Study coordinator: Claire CARDAILLAC
• Email: claire.cardaillac@chu-nantes.fr
• Phone: +33 2 53 48 23 50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.