• Botulinum Toxin for Pelvic Pain in Women With Endometriosis

  NCT01553201

  CompletedInterventionalPhase 1Phase 2Updated Jul 28, 2020
• Botox for Chronic Pelvic Pain

  NCT06796985

  RecruitingInterventionalPhase 1Updated Jun 17, 2026
• Multicenter Randomized Double-blind Study Evaluating the Effects of Botulinum Toxin A Associated With ropivacaïne Versus ropivacaïne Alone in the Treatment of the Myofascial Pelviperineal Pain

  NCT01967524

  CompletedInterventionalPhase 3Updated Dec 15, 2016
• Injection With OnabotulinumtoxinA (Botox) for the Treatment of Chronic Pelvic Pain

  NCT02173405

  CompletedInterventionalPhase 1Updated May 10, 2022
• Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia

  NCT01331356

  CompletedInterventionalPhase 2Updated Oct 7, 2013
• A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management

  NCT05062902

  Not yet recruitingInterventionalEarly Phase 1Updated Aug 19, 2025

ClinicalTrials.gov ID

NCT06995287

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

222Estimated

Last Update Posted

Jul 13, 2026Actual

Start Date

Feb 9, 2026Actual

Primary Completion Date

Jun 9, 2028Estimated

Completion Date

Sep 9, 2028Estimated

Official Title

Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea: A Prospective, Multicenter, Double-Blind, Randomized Placebo-Controlled Study.

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.

Detailed Description

This trial is multicenter, placebo-controlled, randomized with center-based stratification, double-blind and prospective. The treatment consists of a single injection follow by 6 months of follow-up.

• Primary Dysmenorrhea
• Chronic Pelvic Pain

• Xeomin
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Nantes University HospitalOTHER

Collaborators

Merz Pharmaceuticals GmbHINDUSTRY

Ministry of Health, FranceOTHER_GOV

Lea.Delbos@chu-angers.fr33 2 41 35 64 92

christie.rebahi@chu-brest.fr33 2 98 22 35 32

Victoire.DELPORTE@chu-lille.fr33 3 20 44 66 41

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