EUCTR2004-000472-14-ES进行中（未招募）1 期
A multicenter, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the efficacy and safety of four different doses of Org 50081 in the treatment of moderate to severe vasomotor symptoms associated with the menopause
V Organon0 个研究点目标入组 900 人开始时间: 2004年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
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
入选标准
- •1. postmenopausal women, defined as:
- •12 months of spontaneous amenorrhea; OR
- •6 months of spontaneous amenorrhea with serum FSH levels>40 mIU/mL; OR
- •6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- •In case the menopausal status of a subject is unclear because of a hysterectomy,
- •the serum FSH level must be >40 mIU/mL. If the date of the last menstruation is
- •not clear because of perimenopausal hormone use, then the subject must have a
- •serum FSH level >40 mIU/mL after completion of a washout period (see exclusion
- •criteria below).
- •2. age = 40 and = 65 years;
- •3. body mass index (BMI) = 18 and = 32 kg/m2;
- •4. minimum of 7 moderate to severe hot flushes per day or 50 per week, as
- •quantified from daily diary recordings during at least 7 days preceding
- •randomization to trial medication;
- •5. able to handle the electronic diary device after training and having at least 80%
- •compliance on complete daily diary entries during the period prior to randomization;
- •6. give voluntary written informed consent after the scope and nature of the
- •investigation have been explained, before screening evaluations.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •7. history or presence of any malignancy, except non-melanoma skin cancers;
- •8. any clinically unstable or uncontrolled renal, hepatic, endocrine, respiratory,
- •hematological, neurological, cardiovascular or cerebro-vascular disease that
- •would put the subject at safety risk or mask measure of efficacy;
- •9. history of seizures or epilepsy;
- •10. history or presence of clinically significant depression or other psychiatric
- •disorder which, in the opinion of the investigator, might compromise or confound
- •the subject’s participation in the trial;
- •11. abnormal, clinically relevant vaginal bleeding;
- •12. any clinically relevant (opinion of investigator) abnormal finding during physical,
- •gynecological and breast examination at screening;
- •13. abnormal, clinically relevant results of mammography. Mammography must have
- •been performed within the last 9 months prior to screening, otherwise it must be
- •done before inclusion into the trial. For non-US sites, if local laws or guidelines
- •do not allow or advise such frequent mammograms, the documented local laws
- •or guidelines should be followed;
- •14. abnormal cervical smear test results (corresponding to Pap III and higher,
- •including LSIL, HSIL, CIN 1 and higher). A cervical smear must have been performed within the last 9 months prior to screening, otherwise it must be done
- •before inclusion into the trial;
- •15. hematological or biochemical values at screening outside the reference ranges
- •considered clinically relevant in the opinion of the investigator;
- •16. high blood pressure (sitting systolic BP > 170 mmHg and/or diastolic BP > 100
- •17. use of any drug product containing estrogens, progestins, androgens or tibolone
- •prior to screening (and up to and including randomization) within:
- •1 week for prior vaginal hormonal products (rings, creams, gels)
- •4 weeks for prior transdermal products
- •8 weeks for prior oral products
- •8 weeks for intrauterine therapy
- •6 months for prior implant, pellet or injectable drug product;
- •18. any of the following treatments within the last 4 weeks prior to screening (and up to and including randomization):
- •tricyclic antidepressants, SNRIs, SSRIs, MAO-inhibitors, mirtazapine
- •antianxiety drugs, antipsychotics
- •coumarin-derivatives
- •a-adrenergic agents (e.g. clonidine, methyldopa)
- •ß-blockers (e.g., propranolol)
- •dopamine agonists/antagonists (e.g., veralipride, bromocriptine, domperidone)
- •opiates, barbiturates
- •raloxifene
- •homeopathic menopausal preparations or other preparations intended to treat
- •climacteric or CNS symptoms (e.g. Black Cohosh, St. John’s Wort, isoflavone
- •supplements)
- •hepatic microsomal enzyme-inducing drugs or drugs known to affect or
- •interfere with the pharmacokinetics of mirtazapine;
- •19. any condition or disease that could affect or int
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