2025-520638-53-00招募中3 期
Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection via Hysteroscopy in Severe Primary Dysmenorrhea: A Prospective, Multicenter, Double-Blind, Randomized Placebo-Controlled Study. HYSTEROXINE Study
Centre Hospitalier Universitaire De Nantes8 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2025年7月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 222
- 试验地点
- 8
- 主要终点
- The primary endpoint is the response (favorable versus unfavorable) to the Patient Global Impression of Improvement (PGI-I) questionnaire at 3 months after the intra-myometrial injection. The response is considered favorable when the PGI-I score is 1 or 2.
研究概览
简要总结
Evaluation of the global impression of improvement at 3 months following treatment with intra-myometrial botulinum toxin injections via hysteroscopy in women with severe primary dysmenorrhea unresponsive to first-line medical treatment, compared to intra-myometrial placebo injections.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall
- 盲法
- Double (Investigator, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women who are not menopausal
- •Experiencing severe dysmenorrhea, defined by an average pain intensity score of ≥ 6/10 on a Visual Analog Scale over the past 3 months at the inclusion visit
- •Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Step I and II, NSAIDs)
- •Having a pelvic MRI performed within 6 months prior to the inclusion 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
排除标准
- •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
- •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
结局指标
主要结局
The primary endpoint is the response (favorable versus unfavorable) to the Patient Global Impression of Improvement (PGI-I) questionnaire at 3 months after the intra-myometrial injection. The response is considered favorable when the PGI-I score is 1 or 2.
The primary endpoint is the response (favorable versus unfavorable) to the Patient Global Impression of Improvement (PGI-I) questionnaire at 3 months after the intra-myometrial injection. The response is considered favorable when the PGI-I score is 1 or 2.
次要结局
- Average and maximum intensity of dysmenorrhea evaluated using a Visual Analog Scale and duration (in days) during the last cycle before injection, then at 3 and 6 months.
- Average and maximum intensity of pelvic pain outside of menstruation, evaluated using a Visual Analog Scale before injection, then at 1, 3, and 6 months, and duration (in days).
- Average and maximum intensity of pain during the last sexual intercourse, evaluated using a Visual Analog Scale before injection, then at 1, 3, and 6 months.
- Sexual function scale, Female Sexual Function Index (FSFI), evaluated before injection, then at 1, 3, and 6 months.
- Central sensitization pain score, Convergences PP, evaluated before injection, then at 3 months
- Higham score for evaluating menstrual blood loss, assessed before injection, then at 3 and 6 months. Duration (in days) of menstruation during the last cycle evaluated before injection, then at 3 and 6 months.
- Global quality of life score SF-36 and specific quality of life score EHP-5, evaluated before injection, then at 1, 3, and 6 months.
- Number of days of school or work absenteeism during the last month, assessed before injection, then at 1, 3, and 6 months
- Anxiety score STAI-Y evaluated before injection and at 3 months. Depression score, Beck Depression Inventory (BDI-II), evaluated before injection and at 3 months.
- Percentage of overall improvement (0-100%) evaluated at 1, 3, and 6 months. Patient Global Impression of Improvement (PGI-I) evaluated at 1 and 6 months. Patient’s willingness to undergo the intervention again (Yes/No) at 6 months and collection of justification.
- Pain intensity experienced during the procedure and at 5 minutes, evaluated using a Visual Analog Scale
- Adverse effects related to the injections collected in the immediate postoperative period, then at 1, 3, and 6 months
- Occurrence of emergency consultations in the postoperative period, evaluated at 1 month
- For the exploratory analysis of the MEOPA subgroup: primary endpoint, pain during the procedure, willingness to undergo the intervention again, adverse effects, and postoperative consultations
- For the exploratory analysis of the hormonal treatment subgroup: all primary and secondary endpoints
研究者
Claire CARDAILLAC
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (8)
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