Status:
NOT_YET_RECRUITING
Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Merz Pharmaceuticals GmbH
Ministry of Health, France
Conditions:
Primary Dysmenorrhea
Chronic Pelvic Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 dysmenorrh...
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.
Eligibility Criteria
Inclusion
- Adult women who are not menopausal,
- Experiencing severe dysmenorrhea, defined as an average pain intensity score ≥ 6/10 on a Numerical Rating Scale (NRS) over the past 3 months at the inclusion visit,
- 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 6 months prior to the inclusion 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT06995287
Start Date
June 1 2025
End Date
January 1 2028
Last Update
May 29 2025
Active Locations (8)
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1
Clinique axium / Centre resilience
Aix-en-Provence, France
2
CHU Angers
Angers, France
3
CHU Brest
Brest, France
4
CHU Lille
Lille, France