Actively Recruiting
Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study
Led by Nantes University Hospital · Updated on 2026-02-12
222
Participants Needed
8
Research Sites
13 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
Researchers are evaluating the effect of intramyometrial botulinum toxin injections given via hysteroscopy on severe primary dysmenorrhea in women who have not found relief from first-line medical treatments. This multicenter, randomized, double-blind, placebo-controlled trial aims to compare the global impression of improvement at 3 months after the injection. The study is led by Nantes University Hospital and includes a 6-month follow-up period to assess various pain and quality of life measures. Participants receive a single injection administered under local anesthesia through hysteroscopy, either with botulinum toxin type A (Xeomin) or a placebo. After the procedure, patients are followed remotely at 1 month and 6 months to complete questionnaires, and they have an in-person consultation at 3 months for evaluation and additional questionnaires. The study includes monitoring pain intensity during and after the procedure, as well as assessing sexual function, anxiety, depression, and absenteeism related to pain. Women in the study complete multiple assessments including pain intensity scores for dysmenorrhea and pelvic pain, sexual function index, anxiety and depression inventories, and quality of life questionnaires. Researchers also track adverse events, emergency visits, and overall improvement percentages. Follow-up visits and remote questionnaires help monitor the participants' status over the 6-month period, ensuring adherence and thorough evaluation of outcomes related to pain and daily functioning.
CONDITIONS
Brief 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
- Severe dysmenorrhea with an average pain score of 6 or higher out of 10 over the past 3 months
- Failure of first-line medical treatment including hormonal therapy and appropriate analgesics
- Pelvic MRI within 6 months showing no deep infiltrating endometriosis or endometrioma, reviewed by expert radiologists
- Use of a highly effective contraception method with less than 1% failure rate during the entire follow-up
- Negative urine pregnancy test on the day of the procedure
- Signed informed consent at the visit one month before the procedure
You will not qualify if you...
- Pregnant or planning pregnancy during the study period
- Currently breastfeeding
- Refusal to use effective contraception during and for 6 months after the study
- Contraindications to botulinum toxin, including generalized muscle disorders and hypersensitivity
- Treatment with aminoglycosides, muscle relaxants, or amino-4-quinolines
- Bleeding disorders or use of anticoagulants
- Vaginal or upper genital tract infection
- Participation in another interventional clinical trial
- Inability to cooperate or understand study requirements
- Subject to legal protection measures
- Not affiliated with the French social security system
- No internet access to complete questionnaires at months 1 and 6
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single intramyometrial injection via hysteroscopy under local anesthesia.
1 treatment visit (in-person)
Duration - 6 months
Participants complete questionnaires remotely at 1 month and 6 months, and attend a postoperative consultation in person at 3 months.
Remote follow-up at 1 and 6 months, 1 in-person visit at 3 months
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
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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