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

NCT06995287 | Recruiting Phase 3

• 2 other identifiers: RC24_04282025-520638-53-00
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Primary dysmenorrhea; injection; Botulimum toxin, Type A

Outcome Measures

Primary Outcomes (1)

• Patient Global Improvement

  The response (favorable versus unfavorable) to the Patient Global Impression of Improvement questionnaire at 3 months following intra-myometrial injection. A response is considered favorable when the score of Patient Global Impression of Improvement questionnaire is 1 or 2. Patient Global Impression of Improvement questionnaire is self-assessment scale ranging from 1 (Very much improved) to 7 (Very much worsened).

  3 months

Secondary Outcomes (30)

• Average intensity of dysmenorrhea

  6 months

• Maximum intensity of dysmenorrhea

  6 months

• Duration of dysmenorrhea

  6 months

• Average intensity of non-menstrual pelvic pain

  6 months

• Maximum intensity of non-menstrual pelvic pain

  6 months

Study Arms (2)

Botulinum toxin type A

EXPERIMENTAL

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.

Drug: Xeomin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Xeomin DRUG

One injection will be performed via hysteroscopy under local anesthesia.

Botulinum toxin type A

Placebo DRUG

One injection will be performed via hysteroscopy under local anesthesia.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women who are not menopausal,
• Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Level I and II analgesics, and NSAIDs),
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead
• Merz Pharmaceuticals GmbH: collaborator
• Ministry of Health, France: collaborator

Study Sites (8)

Clinique axium / Centre resilience

Aix-en-Provence, France

NOT YET RECRUITING

CHU Angers

Angers, France

NOT YET RECRUITING

CHU Brest

Brest, France

NOT YET RECRUITING

CHU Lille

Lille, France

NOT YET RECRUITING

Hôpital de la Croix-Rousse

Lyon, France

NOT YET RECRUITING

CHU Nantes

Nantes, France

RECRUITING

Clinique Brétéché

Nantes, France

NOT YET RECRUITING

CHU Rennes

Rennes, France

NOT YET RECRUITING

MeSH Terms

Interventions

incobotulinumtoxinA

Central Study Contacts

Claire CARDAILLAC

CONTACT

+33 2 53 48 23 50; claire.cardaillac@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 29, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): June 9, 2028
• Study Completion (Estimated): September 9, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (8)