NCT06995287 Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea
| NCT ID | NCT06995287 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nantes University Hospital |
| Condition | Primary Dysmenorrhea |
| Study Type | INTERVENTIONAL |
| Enrollment | 222 participants |
| Start Date | 2026-02-09 |
| Primary Completion | 2028-06-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 222 participants in total. It began in 2026-02-09 with a primary completion date of 2028-06-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06995287 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Primary Dysmenorrhea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06995287 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 222 participants.
Is NCT06995287 currently recruiting?
Yes, NCT06995287 is actively recruiting participants. Contact the research team at claire.cardaillac@chu-nantes.fr for enrollment information.
Where is the NCT06995287 trial being conducted?
This trial is being conducted at Aix-en-Provence, France, Angers, France, Brest, France, Lille, France and 4 additional locations.
Who is sponsoring the NCT06995287 clinical trial?
NCT06995287 is sponsored by Nantes University Hospital. The trial plans to enroll 222 participants.