A Randomised, Double Blind, Placebo Controlled, Multicentre, Cross Over Proof of Concept Study to Investigate the Efficacy and Safety of Pre Emptive Administration of Repeated, Oral Doses of VA111913 TS for the Alleviation of Dysmenorrhoea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Vantia Ltd
- 入组人数
- 146
- 试验地点
- 4
- 主要终点
- Pain assessed using standard scoring system
研究概览
简要总结
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
详细描述
Dysmenorrhoea is suffered by between 50% and 90% of women of child bearing age. Up to 30% of these women are non-responsive to the currently prescribed therapies. As such it represents an area of unmet medical need. VA111913 inhibits vasopressin-induced contractions of human myometrial strips and human myometrial blood vessels in vitro. By this mechanism, it is anticipated that the pain of dysmenorrhoea, a condition in which myometrial tone and contractions are increased and blood flow to the uterus is decreased compared to normal, may be reduced.
Subjects will be dosed with VA111913 TS and placebo in a cross over design during two consecutive menstrual cycles. They will be dosed for up to a maximum of 6 days, beginning 2 days before the onset of menstruation. Subjects will then assess the menstrual pain, bleeding and amount of analgesia required to treat symptoms during each cycle
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 35 years old
- •Not pregnant
- •History of primary dysmenorrhoea
- •Regular menstrual cycles
- •Signed informed consent
排除标准
- •Known secondary dysmenorrhoea
- •Concomitant use of regular prescription or non prescription medications or herbal remedies
- •Any clinically significant medical history or active disease
- •Participation in another clinical study in the last 3 months
- •Contraindication to chosen rescue medications or allergy to their constituents
- •Other protocol defined eligibility criteria may apply
研究组 & 干预措施
VA111913 100mg twice daily
干预措施: VA111913 TS and placebo (Drug)
Starch pill
干预措施: VA111913 TS and placebo (Drug)
结局指标
主要结局
Pain assessed using standard scoring system
时间窗: 3 months
次要结局
- Assessment of treatment effectiveness(3 months)
- Requirement for rescue medication(3 months)
- Assessment of menstrual bleeding(3 months)
- PK assessments(3 months)
- Safety assessed by laboratory findings, vital signs, ECGs and AEs(3 months)