BridgeMD
Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection via Hysteroscopy in pelvic pain suggestive of dysmenorrhea: A Prospective, Multicenter, Double-Blind, Randomized Placebo-Controlled Study. HYSTEROXINE Study
EU CTIS ID: 2025-520638-53-00
What this study is testing
Assessment of the global impression of improvement at 3 months following hysteroscopically guided intra-myometrial botulinum toxin injections in women with severe dysmenorrhea-like pelvic pain who have failed first-line medical treatment, compared with intra-myometrial placebo injections.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult women who are not menopausal
- Presenting: - Either severe primary dysmenorrhea defined by an average Visual Analog Scale score over the last 3 months ≥ 6/10 at the inclusion visit, - Or, in the case of amenorrhea under hormonal treatment, severe chronic pelvic pain (average Visual Analog Scale ≥ 6/10 over the last 3 months), cramp-like in nature, located in the pelvic region, and described as similar to the initial dysmenorrhea pain.
- Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Step I and II, NSAIDs)
- Having a pelvic MRI performed within 1 year prior to the randomization visit, showing no evidence of deep pelvic endometriosis, endometriomas or myoma after systematic re-evaluation by the radiologists at the expert center managing the patient (if the pelvic MRI is deemed of insufficient quality for interpretation, it will be repeated at the center).
- Using a highly effective contraception method (failure rate <1%) for the entire duration of the patient's follow-up. Highly effective contraception methods are defined as one of the following: combined hormonal contraception (containing estrogens and progestins) with ovulation inhibition (oral, intravaginal, transdermal), progestin-only hormonal contraception with ovulation inhibition (oral, injectable, implantable), intrauterine device (IUD), hormone-releasing intrauterine system (IUS), condoms, bilateral tubal occlusion, vasectomized partner, sexual abstinence.
- Presenting with a negative blood pregnancy test at the inclusion visit and a negative urine test on the day of the procedure.
You likely can't join if
- Pregnant patient or planning pregnancy throughout the duration of the study
- Participation in another interventional clinical research trial
- Having cooperation and/or understanding that does not allow strict adherence to the conditions outlined in the protocol
- Being under a legal protective measure (guardianship, tutorship, judicial safeguard)
- Patient presenting with deep pelvic endometriosis or a fibroid
- Being on anticoagulant treatment between Month -1 and Month 1.
See the full eligibility criteria
Who can join
- Adult women who are not menopausal
- Presenting: - Either severe primary dysmenorrhea defined by an average Visual Analog Scale score over the last 3 months ≥ 6/10 at the inclusion visit, - Or, in the case of amenorrhea under hormonal treatment, severe chronic pelvic pain (average Visual Analog Scale ≥ 6/10 over the last 3 months), cramp-like in nature, located in the pelvic region, and described as similar to the initial dysmenorrhea pain.
- Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Step I and II, NSAIDs)
- Having a pelvic MRI performed within 1 year prior to the randomization visit, showing no evidence of deep pelvic endometriosis, endometriomas or myoma after systematic re-evaluation by the radiologists at the expert center managing the patient (if the pelvic MRI is deemed of insufficient quality for interpretation, it will be repeated at the center).
- Using a highly effective contraception method (failure rate <1%) for the entire duration of the patient's follow-up. Highly effective contraception methods are defined as one of the following: combined hormonal contraception (containing estrogens and progestins) with ovulation inhibition (oral, intravaginal, transdermal), progestin-only hormonal contraception with ovulation inhibition (oral, injectable, implantable), intrauterine device (IUD), hormone-releasing intrauterine system (IUS), condoms, bilateral tubal occlusion, vasectomized partner, sexual abstinence.
- Presenting with a negative blood pregnancy test at the inclusion visit and a negative urine test on the day of the procedure.
- Having signed the informed consent for the study no later than Day 0
What rules you out
- Pregnant patient or planning pregnancy throughout the duration of the study
- Participation in another interventional clinical research trial
- Having cooperation and/or understanding that does not allow strict adherence to the conditions outlined in the protocol
- Being under a legal protective measure (guardianship, tutorship, judicial safeguard)
- Patient presenting with deep pelvic endometriosis or a fibroid
- Being on anticoagulant treatment between Month -1 and Month 1.
- Infection or inflammation at the injection site
- Postmenopausal woman (defined as at least 12 months of amenorrhea not related to hormonal treatment)
- Not being affiliated with the French Social Security system
- Not having the ability to connect to the internet to complete the questionnaires at M1 and M6
- Unexpected discovery of an endocavitary lesion not previously diagnosed (polyp, fibroid, or uterine malformation) during the Day 0 visit.
- Currently breastfeeding
- Refusal to use highly effective contraception during the study and for the 6 months following the study
- Having a contraindication to botulinum toxin: - Generalized muscle activity disorders (myasthenia, Lambert-Eaton syndrome), - Ongoing treatment with aminoglycosides, peripheral muscle relaxants, or amino-4-quinolines, - Hypersensitivity to the active substance, human albumin, or sucrose
- Having coagulation disorders
- Having an active vaginal or upper genital infection
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.