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New treatment option for Primary Dysmenorrhea
Official title Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea
ClinicalTrials.gov ID: NCT06995287
What this study is testing
What is Xeomin?
Xeomin is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for primary dysmenorrhea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Level I and II analgesics, and NSAIDs),
You likely can't join if
- 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,
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aix-en-Provence, France
- Angers, France
- Brest, France
- Lille, France
- Lyon, France
- Nantes, France
- Rennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aix-en-Provence, France; Angers, France; Brest, France; Lille, France; Lyon, France; Nantes, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.