A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 475
- 试验地点
- 12
- 主要终点
- Effect on DRSP Total symptom score
研究概览
简要总结
The objective of this phase IIb study is to evaluate the effect and safety of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD). Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms. Sepranolone is an endogenous steroid.
详细描述
The objective of this phase IIb study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) in comparison to placebo, administrated during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms and impairment of symptoms on daily life of the patients. The scale is Daily Record of Severity of Problems (DRSP). Preceding the treatment period, the diagnosis of PMDD will be established in the study participants by at lest two menstrual cycles of prospective DRSP ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The Total symptom score of the DRSP will constitute the primary variable and the late luteal phase ratings in the respective menstrual cycles, before and during treatment, will be used.
The study will also include a follow-up (no treatment) cycle before patients final visit.
The study is conducted in four European countries (Sweden, Germany, Poland and United Kingdom) and will include up to 225 patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •have PMDD according to DSM-5 verified in two menstrual cycles
- •have a regular menstrual cycle of 24-35 days cycle,
- •use double barrier contraception, non-hormonal IUD, be truly sexually abstinent, or subject or her partner has been surgically sterilized,
排除标准
- •steroid hormonal treatment or treatment with psychopharmaceuticals during previous three months
- •treatments for premenstrual syndrome (PMS) or PMDD
- •history of or significant medical condition ongoing
- •be pregnant or plan a pregnancy within the study period
研究组 & 干预措施
Sepranolone (UC1010) low dose
Sepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase
干预措施: Sepranolone (UC1010) low dose (Drug)
Sepranolone (UC1010) high dose
Sepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase
干预措施: Sepranolone (UC1010) high dose (Drug)
Placebo
Placebo administered subcutaneously (SC) during the luteal phase
干预措施: Placebo (Drug)
结局指标
主要结局
Effect on DRSP Total symptom score
时间窗: Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment.
Change in DRSP Total symptom score (Daily Record of Severity of Problems) measured during the luteal phase (i.e. the week before menstruation) before and during treatment
次要结局
- Incidence of Treatment-Emergent Adverse Events(Starting from first dose given until 1 months after treatment stop)