2023-503688-41-00招募中3 期
Efficacy of Vitex agnus-castus BNO 1095 (20 mg) in women with primary dysmenorrhea
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Bionorica SE
- 入组人数
- 300
- 试验地点
- 38
- 主要终点
- Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score assessed in the cramping window of Cycle 5 compared to Baseline AND b) no increase in the number of standard pain relief medication taken in the cramping window of Cycle 5 compared to Baseline.
研究概览
简要总结
To determine if primary dysmenorrhea improves in women treated with Vitex agnus-castus BNO 1095 20 mg compared to placebo over a treatment duration of 3 menstrual cycles (cramping windows of Cycles 3-5).
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up phase
- 盲法
- Double (Subject, Monitor, Investigator, Analyst)
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
- 是
入选标准
- •Women aged 18-49 years who have the capacity for consenting
- •Patient has been informed of the nature, scope, and relevance of the clinical trial, voluntary agrees in participation and the trial provisions, and has duly signed the approved informed consent form (ICF)
- •Diagnosed primary dysmenorrhea (see Section 5.1, Table 1)
- •If patients take pain relief medication for primary dysmenorrhea, this medication should be taken unchanged with regard to application form and kind of medication including strength … [due to commercially confidential information restrictions]. Note: Medication (drugs) for primary dysmenorrhea as mono- or combination therapy in form of tablets/capsules regularly used by the patient before Screening is allowed to be used as standard pain relief medication during the trial apart from non-medication methods. A complete list of allowed pain relief medication is attached to the protocol (Appendix 2). … [due to commercially confidential information restrictions].
- •Patients with a regular menstrual cycle duration of ≥24 to ≤38 days
- •Patients agreeing to use one of the following contraception methods throughout the trial: a. Bilateral tubal occlusion b. Vasectomized partner (provided that the partner is the sole sexual partner of the woman and has received medical assessment of the surgical success) c. Sexual abstinence Abstinence is only accepted as true abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal) is not an acceptable method of contraception. d. Male or female condom with or without spermicide e. Cap, diaphragm, or sponge with spermicide.
排除标准
- •Non-menstruating women
- •Known or suspected acute infection of gonorrhea, syphilis and/or chlamydia at Screening
- •Current or past estrogen sensitive cancer or pituitary disorder that, in the investigator’s opinion, would make the patient not suitable for the trial.
- •Women who are breastfeeding, pregnant (positive pregnancy test at Screening), or planning to become pregnant during the trial.
- •Fewer than 3 menstrual cycles before Screening following delivery, abortion, miscarriage, or lactation.
- •Current severe physical or mental illness.
- •Patient does not agree to avoid daily smoking.
- •History of alcohol, drug, or medicine abuse within 1 year prior to Screening, or positive for drugs or medicines of abuse in the laboratory analysis performed at Screening.
- •Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- •Hypersensitivity to Vitex agnus-castus, lactose or any of the excipients of the IMP or to any ingredients of the standard pain relief medication.
- •Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- •Clinically diagnosed secondary dysmenorrhea (e.g., fibroids, uterine adenomyosis, endometriosis, pelvic inflammation, ovarian pathologies, or other pelvic diseases)
- •Employees of the sponsor or site staff or direct relatives of the site staff.
- •Legal incapacity or limited legal capacity.
- •Patients not able to follow trial instructions or assessments or to participate in the trial … [due to commercially confidential information restrictions] or unable to understand written and verbal instruction, in particular regarding the risks and inconveniences that the patients will be exposed to during participation in the clinical trial.
- •Participation in another interventional clinical trial during the last month before Screening.
- •Use of Vitex agnus-castus containing preparation or product within the last 3 months before Screening.
- •Current intake or intake within the last 4 weeks before Screening of dopamine agonists, dopamine antagonists, estrogens, or antiestrogens that would make the patient not suitable for the trial.
- •Dysmenorrhea resulting from the use of an intrauterine device.
- •Use of hormonal contraceptives (oral, intravaginal, transdermal, injectable, implantable), intrauterine device, or intrauterine hormone-releasing system within 6 months prior to the trial and not willing to waive it during the entire trial period.
- •Any surgical treatments in the past (e.g., due to myoma) that may cause pain, adhesions or scarring in the lower abdomen Note: Further diagnostic examination (e.g., laparoscopy for differential diagnosis, exclusion of endometriosis) if deemed necessary by the investigator will be outside the trial protocol and reimbursement.
- •Known or suspected gastrointestinal or urological conditions that may cause abdominal and/or pelvic pain, such as colitis, appendicitis, irritable bowel syndrome, cholelithiasis, interstitial cystitis, cystitis, urolithiasis, and other conditions that, according to the investigator’s judgement, are not suitable for the trial.
- •Known or suspected gynecological complaints e.g., premenstrual abdominal pain, deep dyspareunia, uterine fibroids and polyps, or chronic pain (abdominal, dorsal, urogenital).
- •Known instable diseases e.g., psychiatric, cardiovascular, or endocrine disorders.
- •Body mass index <18.5 or >34.9 kg/m² at Screening.
结局指标
主要结局
Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score assessed in the cramping window of Cycle 5 compared to Baseline AND b) no increase in the number of standard pain relief medication taken in the cramping window of Cycle 5 compared to Baseline.
Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score assessed in the cramping window of Cycle 5 compared to Baseline AND b) no increase in the number of standard pain relief medication taken in the cramping window of Cycle 5 compared to Baseline.
次要结局
未报告次要终点
研究者
Kundeninfoservice
Scientific
Bionorica SE
研究点 (38)
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