EUCTR2007-001295-36-DE进行中（未招募）不适用
A parallel-group, double-blind, randomized, placebo-controlled,active comparator, multicenter study to evaluate the efficacy,safety, tolerability and pharmacokinetics of two doses ofGSK232802 administered orally as monotherapy for 12 weeksin healthy postmenopausal women with moderate to extremelysevere vasomotor symptoms - CNA109586
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 400 人开始时间: 2007年5月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1.Postmenopausal women aged 40 to 65 years old; postmenopausal defined as:
- •i.Amenorrheic for at least 12 consecutive months* OR
- •ii.At least 6 weeks post-surgical bilateral oophorectomy† with or without hysterectomy.
- •*Note: Although duration of amenorrhea is initially determined by subject history at the time of the screening visit (Visit 1), menopausal status must be confirmed by demonstrating levels of follicle stimulating hormone (FSH) >40 mIU/mL (SI: >40 IU/L) and estradiol <35pg/mL (SI: <128pmol/L) at entry. Screening reports provided by the Central Laboratory must be carefully reviewed to determine menopause eligibility prior to conducting Visit 2 assessments. In the event a subject’s menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH and/or estradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility should be discussed with the study medical monitor.
- •†For women who are surgically menopausal, a copy of the pathology report or a statement on letterhead from the subject’s physician documenting both ovaries have been removed or biochemical evidence of post-menopausal status as noted above is required prior to conducting Visit 2 assessments.
- •2.A minimum average frequency of seven daily moderate to extremely severe hot flashes or episodes of night sweats sufficient to cause the patient to seek treatment (these episodes must be documented during the baseline period and the subject must have recorded frequency and severity of symptoms for a minimum of eight days in order to be eligible for randomization). This average frequency will be calculated by summing the number of moderate, severe, and extremely severe VMS events during the baseline period and dividing by the total number of non-missing days during this period, with details related to the definition of non-missing days described in Section 6.3.1.
- •3.BMI within the range 19 to 35 kg/m2, inclusive.
- •4.Subject has provided signed and dated written informed consent before admission to the study.
- •5.Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
- •Please see protocol for full list
- •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
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1.Investigator considers subject unfit for the study as a result of medical history, physical examination, or screening tests.
- •2.Use of prescription or non-prescription drugs
- •ii.Use of putative therapies for VMS relief within the past 30 days or 5 half-lives prior to conduct of Visit 1 assessments. Use of non-medication treatments for VMS, such as acupuncture and biofeedback, and other complementary or alternative therapies for VMS relief (with the exception of black cohosh and red clover which require a specified washout previously noted) must be discontinued at Visit 1.
- •iii.Use of weight loss drugs within 3 months of the first dose of investigational product. Other complementary or alternative therapies for weight reduction must be discontinued at Visit 1. See SPM for listing.
- •iv.Use of pravastatin, rosuvastatin, or pitavastatin within the past 30 days or 5 half-lives of the first dose of investigational product
- •v.Use of bupropion, orphenadine, cyclophosphamide, efavirenz, ifosfamide, or methadone, or use of paclitaxel, torsemide, amodiaquine, repaglinide, rosiglitazone, or pioglitazone within the past 30 days or 5 half-lives of the first dose of investigational product .
- •3.Use of investigational drug within the past 30 days or 5 half-lives before the first dose of investigational product.
- •4.Uterine disease or medical condition including:
- •Bi-layer endometrial thickness greater than 5mm as determined by TVUS, or for women with a non-informative TVUS, a single layer thickness of greater than 3 mm determined by SIS; presence of fibroids that obscure evaluation of endometrium by TVUS;
- •History of uterine cancer; evidence of endometrial hyperplasia or cancer as assessed by a screening endometrial biopsy.
- •Evidence of an endometrial polyp with hyperplastic or malignant epithelium;
- •Unexplained or unusual endometrial bleeding; or uterine surgery within the past 6 months;
- •*Note: hysterectomy must have been conducted at least 6 weeks prior to screening Visit 1. See also Inclusion criterion 1.
- •Abnormal cervical Pap smear with evidence of cervical dysplasia greater than or equal to low grade squamous intraepithelial lesion or with a diagnosis of atypical squamous cells of undetermined significance that is HPV High Risk positive, or glandular lesions including but not limited to atypical glandular cells of undetermined significance, adenocarcinoma in situ or malignancy
- •5.History of breast or ovarian cancer. Any clinically significant findings on mammography suspicious of breast malignancy that would require additional clinical testing to rule out breast cancer
- •6.Cardiovascular conditions including:
- •i.Systolic blood pressure (BP) outside the range 80 to 150 mmHg, diastolic BP outside the range 50 to 90 mmHg, and/or heart rate outside the range 40 to 100 bpm. Subjects with mild to moderate hypertension who are controlled on a stable antihypertension regimen may be enrolled if they meet the inclusion/exclusion criteria.
- •ii.Symptomatic or asymptomatic arrhythmia of any clinical significance.
- •iii.Any clinically significant abnormality identified on the screening 12-lead ECG. Subjects with QTc prolongation will be excluded.
- •iv.Has a documented history of myocardial infarction, angina, or has undergone coronary artery bypass surgery and/or percutaneous transluminal coronary angioplasty.
- •v.History of venous or arterial thromboembolic disea
研究者
相似试验
进行中（未招募）
不适用
A parallel-group, double-blind, randomized, placebo-controlled, active comparator, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of two doses of GSK232802 administered orally as monotherapy for 12 weeks in healthy postmenopausal women with moderate to extremely severe vasomotor symptoms - NDHealthy postmenopausal women with moderate to extremely severe vasomotor symptomsMedDRA version: 6.1Level: PTClassification code 10058825EUCTR2007-001295-36-ITGlaxoSmithKline Research and Development Ltd400
进行中（未招募）
1 期
A parallel-group, double-blind, randomized, placebo-controlled,active comparator, multicenter study to evaluate the efficacy,safety, tolerability and pharmacokinetics of two doses ofGSK232802 administered orally as monotherapy for 12 weeksin healthy postmenopausal women with moderate to extremelysevere vasomotor symptomsEstudio de grupos paralelos, aleatorizado, doble ciego, controlado con placebo y con comparador activo, multicéntrico, para evaluar la eficacia, seguridad, tolerabilidad y farmacocinética de dos dosis de GSK232802 administrado oralmente en monoterapia durante 12 semanas a mujeres postmenopáusicas sanas con síntomas vasomotores de moderados a muy intensos. - CNA109586Treatment of moderate to extremely severe vasomotor symptoms in healthy postmenopausal women.Tratamiento de síntomas vasomotores de moderados a muy intensos en mujeres postmenopáusicas sanas.EUCTR2007-001295-36-ESGlaxoSmithKline S.A.
进行中（未招募）
1 期
A parallel-group, double-blind, randomized, placebo-controlled, active comparator, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of two doses of GSK232802 administered orally as monotherapy for 12 weeks in healthy postmenopausal women with moderate to extremely severe vasomotor symptoms - CNA109586EUCTR2007-001295-36-GBGlaxoSmithKline Research and Development Limited
进行中（未招募）
不适用
A parallel-group, double-blind, randomized, placebo-controlled,active comparator, multicenter study to evaluate the efficacy,safety, tolerability and pharmacokinetics of two doses ofGSK232802 administered orally as monotherapy for 12 weeksin healthy postmenopausal women with moderate to extremelysevere vasomotor symptoms - CNA109586EUCTR2007-001295-36-SEGlaxoSmithKline Research and Development Limited400
进行中（未招募）
不适用
A randomized, double-blind, parallel group, placebo controlled, multi center dose ranging study of solifenacin succinate (3 mg, 6 mg and 9 mg) in combination with tamsulosin OCAS 0.4 mg compared with solifenacin succinate monotherapy (3 mg, 6 mg and 9 mg) and tamsulosin OCAS 0.4 mg monotherapy in males with lower urinary tract symptoms - SATUREUCTR2006-002072-18-BEAstellas Pharma Europe B.V.840