Prospective, double-blind, placebo-controlled, parallel-group, multi-centre randomized clinical trial to proof efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 FCT in patients suffering from cyclic mastodynia and PMS - Efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 FCT on cyclic mastodynia and PMS

Bionorica SE0 个研究点目标入组 280 人2013年7月5日

概览

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注册库

who.int

开始日期

2013年7月5日

结束日期

待定

最后更新

11年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

发起方

•1\. Females aged 18 to 45 who have signed an ICF at screening visit S\-2 at the latest
•2\. Subject has a history of cyclic mastodynia and PMS at visit S\-2
•3\. Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S\-2 and during run in phase
•4\. At screening visit S\-2 subject is reporting at least one physical PMS symptom (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the COPE symptom list
•5\. At screening visit S\-2 subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the COPE symptom list
•6\. In both run\-in cycles:
•6A. VAS \= 50 at least on one of the days of the late luteal phase
•6B. Cyclic course of the mastodynia, i.e. VAS in the mid follicular phase (maximum value of 7 daily recordings) is less than 75 % of the VAS in the late luteal phase (maximum value of 7 daily recordings)
•6C. At least one physical PMS symptom and one psychic symptom is present on at least one day of the late luteal phase.
•6D. PMS sum score resulting from COPE in the mid follicular phase (sum score of all PMS sum scores across the seven\-day phase) is less than 75 % of the PMS sum score resulting from COPE in the late luteal phase (sum score of all PMS sum scores across the seven\-day phase)

•1\. Hypersensitivity to the active substance or to any of the excipients of the IMP at visit S\-2
•2\. Proof of PMDD at visit S\-2 according to DSM\-IV criteria as defined by APA \[American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders , 4th ed. Text Revision. Washington, DC: American Psychiatric Association, 2000] based on the findings as follows:
•A total of at least 5 premenstrual symptoms with at least one severe mood symptom must be present. The instrument used for retrospective assessment will be a questionnaire according to DSM\-IV criteria.
•In addition, the symptoms
•must have a history of 1\-year duration
•must seriously interfere with work, relationships or social activities
•must not be an exacerbation of another disease
•3\. Intake of any of the following medications before treatment start (visit S\-2 up to visit V0\) and within 6 months prior to visit S 2:
•hypothalamic hormones
•injectable contraceptives: 3\-month injection