EUCTR2021-003929-30-BE进行中（未招募）1 期
INFLUENCE OF OXYBUTYNIN - MEDRING LIGALLI ON OVERACTIVE BLADDER SYMPTOMS IN WOMEN - MedRing-04
igalli BV0 个研究点目标入组 9 人开始时间: 2022年8月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1.Willing to give written informed consent and willing and able to comply with the study protocol.
- •2.Female subjects aged between 18 and 70 years (inclusive)
- •3.Women diagnosed with OAB according to the definition of the International Continence Society (ICS), and responding with a score 3 or higher on question 5a of the ICIQ questionnaire do you have to rush to the toilet to urinate”?
- •4.Subject is in good general health, according to the investigator’s judgement based on medical history, vital signs, physical examination, electrocardiogram (ECG), and laboratory tests performed.
- •5.Body mass index between 18-32 kg·m2 (inclusive) and with a minimum body weight of 50 kg at screening.
- •6.Ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions.
- •7.Using adequate contraception (if applicable).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1.Presence of virginity.
- •2.History of sexual abuse/violence.
- •3.Menstrual bleeding or withdrawal bleeding from oral contraceptive pill expected to occur during conduction of the study.
- •4.Positive urinary pregnancy test at screening or at baseline and/or lactating.
- •5.Having given birth vaginally or by caesarean section 6 months prior to screening
- •6.Having had sexual intercourse or objects inserted vaginally that could potentially lacerate or damage the vaginal wall 24 hours prior to dosing.
- •7.Medical history of intra- and/or transvaginal operations that in the opinion of the investigator may interfere with placement or stability of the MedRing or absorption of oxybutynin.
- •8.Any known significant allergic reactions (urticaria or anaphylaxis) against oxybutynin, or multiple drug allergies (non-active hay fever is acceptable), or known hypersensitivity to components of the MedRing (polypropylene, styrene triblock copolymer, coloring agents, coating, glue).
- •9.Participation in any marketed or investigational drug or device study within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- •10.Botox administration in the pelvic area less than 12 months ago.
- •11.Use of any prescription medication and any other substance that in the opinion of the investigators may influence the outcome of the study within 21 days prior to dosing.
- •12.Use of alcohol during the 24 hours prior to Day 1 of the study.
- •13.Any other condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject.
- •14.Presence of significant postvoid residual urine determined as >100 ml estimated by ultrasound immediately postvoiding.
研究者
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