A Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)

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追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

April 20, 2018

预计主要完成日期

November 30, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Effect on DRSP Total symptom score[ Time Frame: Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment (average of 3 menstrual cycles). ]

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

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Incidence of Treatment-Emergent Adverse Events[ Time Frame: Starting from first dose given until 1 months after treatment stop ]
Recording of adverse events

描述性信息

简略标题 ^ICMJE

A Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)

正式标题 ^ICMJE

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)

简要概况

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.

详细说明

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 225 to 250 patients.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Sepranolone (UC1010) low dose
Subcutaneous (SC) administration
Drug: Sepranolone (UC1010) high dose
Subcutaneous (SC) administration
Drug: Placebo
Subcutaneous (SC) adminstration

研究工具

Experimental: Sepranolone (UC1010) low dose
Sepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase
Experimental: Sepranolone (UC1010) high dose
Sepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase
Placebo Comparator: Placebo
Placebo administered subcutaneously (SC) during the luteal phase

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

225

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

February 28, 2020

预计主要完成日期

November 30, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Main Inclusion Criteria: - 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, Main Exclusion Criteria: - 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

性别

参与研究的性别:

Female

年龄

最小年龄：18 Years ，最大年龄：45 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United Kingdom

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

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研究赞助商 ^ICMJE

Asarina Pharma

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Shaughn O'Brien, MD Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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