NCT06995287招募中3 期
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.
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 222
- 试验地点
- 8
- 主要终点
- Patient Global Improvement
研究概览
简要总结
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.
详细描述
This trial is multicenter, placebo-controlled, randomized with center-based stratification, double-blind and prospective. The treatment consists of a single injection follow by 6 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 dysmenorrhea pain.
- •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 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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
One injection will be performed via hysteroscopy under local anesthesia. The patient will be followed up remotely at M1 and M6 to complete questionnaires, and will be seen in site at M3 for a postoperative consultation and to complete questionnaires.
干预措施: Placebo (Drug)
Botulinum toxin type A
Experimental
One injection will be performed via hysteroscopy under local anesthesia. The patient will be followed up remotely at M1 and M6 to complete questionnaires, and will be seen in site at M3 for a postoperative consultation and to complete questionnaires.
干预措施: Xeomin (Drug)
结局指标
主要结局
Patient Global Improvement
时间窗: 3 months
The response (favorable versus unfavorable) to the Patient Global Impression of Improvement questionnaire at 3 months following intra-myometrial injection. A response is considered favorable when the score of Patient Global Impression of Improvement questionnaire is 1 or 2. Patient Global Impression of Improvement questionnaire is self-assessment scale ranging from 1 (Very much improved) to 7 (Very much worsened).
次要结局
- Average intensity of dysmenorrhea(6 months)
- Maximum intensity of dysmenorrhea(6 months)
- Duration of dysmenorrhea(6 months)
- Average intensity of non-menstrual pelvic pain(6 months)
- Maximum intensity of non-menstrual pelvic pain(6 months)
- Duration of non-menstrual pelvic pain(6 months)
- Average intensity of pain during the most recent sexual intercourse(6 months)
- Sexual function assessed using the Female Sexual Function Index(6 months)
- Central sensitization to pain(3 months)
- Heavy menstrual bleeding assessed using the Higham score(6 months)
- General quality of life(6 months)
- Disease-specific quality of life(6 months)
- Number of days of school or work absenteeism(6 months)
- Anxiety assessed using the State and Tait Anxiety Inventoy-Y scale(3 months)
- Depression evaluated using the Beck Depression Inventory-II(3 months)
- Global improvement percentage(6 months)
- Pain intensity during the procedure(during procedure)
- Pain intensity at 5 minutes post-procedure(5 minutes post-procedure)
- Adverse events related to the injections(6 months)
- Emergency visits following the procedure(1 month)
- Exploratory analysis for the MEOPA subgroup : Primary Outcome(3 months)
- Exploratory analysis for the MEOPA subgroup : Pain intensity during the procedure(during procedure)
- Exploratory analysis for the MEOPA subgroup: Willingness to repeat the intervention(6 months)
- Exploratory analysis for the MEOPA subgroup: Adverse event(6 months)
- Exploratory analysis for the MEOPA subgroup : Emergency visits(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Primary Outcome(3 months)
- Exploratory analysis for the hormonal treatment subgroup : Pain intensity during the procedure(during procedure)
- Exploratory analysis for the hormonal treatment subgroup : Willingness to repeat the intervention(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Adverse event(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Emergency visits(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Duration of dysmenorrhea(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Primary Outcome(3 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Average intensity of dysmenorrhea(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Maximum intensity of dysmenorrhea(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Average intensity of non-menstrual pelvic pain(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Maximum intensity of non-menstrual pelvic pain(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Duration of non-menstrual pelvic pain(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Average intensity of pain during the most recent sexual intercourse(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Sexual function assessed using the Female Sexual Function Index(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Central sensitization to pain(3 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Heavy menstrual bleeding assessed using the Higham score(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : General quality of life(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Disease-specific quality of life(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Number of days of school or work absenteeism(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Anxiety assessed using the State and Tait Anxiety Inventoy-Y scale(3 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Depression evaluated using the Beck Depression Inventory-II(3 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Global improvement percentage(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Pain intensity during the procedure(during procedure)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Pain intensity at 5 minutes post-procedure(5 minutes post-procedure)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Adverse events related to the injections(6 months)
- For the exploratory analysis of subgroups of patients with and without amenorrhea : Emergency visits following the procedure(1 month)
- Exploratory analysis for the hormonal treatment subgroup : Average intensity of dysmenorrhea(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Maximum intensity of dysmenorrhea(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Duration of dysmenorrhea(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Average intensity of non-menstrual pelvic pain(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Maximum intensity of non-menstrual pelvic pain(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Duration of non-menstrual pelvic pain(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Average intensity of pain during the most recent sexual intercourse(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Sexual function assessed using the Female Sexual Function Index(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Central sensitization to pain(3 months)
- Exploratory analysis for the hormonal treatment subgroup : Heavy menstrual bleeding assessed using the Higham score(6 months)
- Exploratory analysis for the hormonal treatment subgroup : General quality of life(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Disease-specific quality of life(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Number of days of school or work absenteeism(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Anxiety assessed using the State and Tait Anxiety Inventoy-Y scale(3 months)
- Exploratory analysis for the hormonal treatment subgroup : Depression evaluated using the Beck Depression Inventory-II(3 months)
- Exploratory analysis for the hormonal treatment subgroup : Global improvement percentage(6 months)
- Exploratory analysis for the hormonal treatment subgroup : Pain intensity at 5 minutes post-procedure(5 minutes post-procedure)
研究者
研究点 (8)
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