EUCTR2012-005042-37-DE进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Bionorica SE
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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 rated moderate or severe (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 5 daily recordings) is less than 75 % of the VAS in the late luteal phase (maximum value of 5 daily recordings)
- •6C. PMS sum score resulting from COPE must be 20.0 or more in the late luteal phase (average of daily recordings documented on days -5 to -1)
- •6D. At least one physical PMS symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present
- •6E. PMS sum score resulting from COPE must not exceed 10 at day 4 of the menstruation
- •6F. PMS sum score resulting from COPE must not exceed 8.0 in the mid follicular phase (average of daily recordings documented on days 6 to 10)
- •7. Compliance for keeping detailed symptom records can be expected
- •8. Subject provides a negative pregnancy test at study start (S-2, V0 and V3 if of childbearing potential) and is willing to use one of the following hormone-free medically acknowledged contraception methods with a PEARL-index < 1 % from enrolment till onset of next menses after study termination:
- •Double-barrier method, e.g. condom* AND occlusive cap (diaphragm or Portio cap or Lea Contraceptivum) with spermicidal foam/gel/film/cream/suppository (* A female condom and a male condom should not be used together as friction between the two can result in either product failing.), OR
- •hormone-free intra uterine device (IUD) AND condom, OR
- •hormone-free IUD AND sponge, OR
- •hormone-free IUD AND spermicidal foam/gel/film/cream/suppository OR
- •vasectomized partner OR
- •sexual abstinence
- •Non childbearing potential group is defined for the intended patient as surgical sterilisation at least three months before the start of the study
- •9. An unsuspicious breast USG/mammogram not older than 12 months ruling out signs of malignancy is available (otherwise arrange breast USG prior to visit S-1, exceptionally prior to V0)
- •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 280
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 (including herbal or homeopathic drugs) before treatment start (visit S-2 up to visit V0) and within 6 months prior to visit S-2:
- •any treatment for mastodynia or premenstrual complaints
- •sexual hormones, combinations and inhibitors
- •pituitary hormones and their inhibitors
- •hypothalamic hormones
- •dopamine-agonists and dopamine-antagonists
- •neuroleptics, antidepressants
- •serotonin-reuptake-inhibitors
- •prolactin-inhibitors or prolactin stimulating preparations
- •drug abuse or continuous intake of NSAIDs or any other analgetics including antirheumatics (up to 2 tablets of paracetamol 500 mg or equivalent per week are allowed)
- •spironolactone
- •androgens
- •gonadotrophin inhibitors
- •diuretics
- •psychotropic agents
- •4. Any psychiatric treatment before treatment start (visit S-2 up to visit V0) and within 12 months prior to visit S-2
- •5. Medical history or presence of any of the following medical conditions/ diseases before treatment start:
- •Uncontrolled diabetes mellitus: Patients with known diabetes mellitus, who have a glycosylated haemoglobin (HbA1c) = 7% as assessed at visit S-1
- •Uncontrolled hypertension: Patients with a diastolic blood pressure > 90 mmHg at visit S-2
- •Known cardiac insufficiency, coronary heart disease, valvular heart disease, cardiac arrhythmia, QT interval prolongation or other severe cardiac disease at visit S 2
- •Known clinically significant organ or systemic diseases or any other relevant medical condition such that in the opinion of the investigator, the significance of the disease or condition will compromise the subject’s participation in the study
- •Known hyperprolactinemia (serum prolactin basal > 50 ng/ml or > 1050 mlU/L)
- •Known hypo-/hyperthyreosis
- •Known hypo-/hyperparathyroidism
- •Known pituitary tumor including prolactinoma
- •Known chronic kidney disease
- •Known gastrointestinal, or liver diseases, such as:
- •a. active peptic gastric ulcer
- •b. malabsorption
- •c. hepatitis
- •endometriosis
- •breast cancer, fibroadenoma, intraductal papilloma or other malignancy within the last 10 years
- •suspicious non-verified finding on any breast ultrasound or mammograms in the past
- •galactorrhea of degree II or III
- •purulent or bloody nipple discharge
- •refractory and/or unverified breast skin- or nipple/areola lesions
- •pregnancy, lactation
- •wish for pregnancy
- •any surgery planned to take place during the trial including breast cyst puncture
- •6. Values of safety laboratory parameters outside normal ranges and clinically relevant as assessed by the investigator at S-1
- •7. At screening: serum thyroid-stimulating hormone (TSH) = 2.5 mU/l
- •8. Parallel part
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