Actively Recruiting
Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea
Led by Nantes University Hospital · Updated on 2026-02-12
222
Participants Needed
8
Research Sites
134 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
M
Merz Pharmaceuticals GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Clinique axium / Centre resilience
Aix-en-Provence, France
Not Yet Recruiting
2
CHU Angers
Angers, France
Not Yet Recruiting
3
CHU Brest
Brest, France
Not Yet Recruiting
4
CHU Lille
Lille, France
Not Yet Recruiting
5
Hôpital de la Croix-Rousse
Lyon, France
Not Yet Recruiting
6
CHU Nantes
Nantes, France
Actively Recruiting
7
Clinique Brétéché
Nantes, France
Not Yet Recruiting
8
CHU Rennes
Rennes, France
Not Yet Recruiting
Research Team
C
Claire CARDAILLAC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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