EUCTR2007-001295-36-IT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 - ND
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 400 人开始时间: 2007年6月19日最近更新:
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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
- •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 IU/mL and estradiol <30ng/L at entry. Screening reports provided by the Central Laboratory must be carefully reviewed to determine menopause eligibility prior to conducting Visit 2 assessments. ?For women who are surgically menopausal, a copy of the pathology report demonstrating both ovaries have been removed and/or biochemical evidence of postmenopausal 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. 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.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 including:
- •i. Hormone therapy (estrogen or estrogen/progestin combination or related
- •products) within the following time period before the first dose of investigational
- •product and during the study:
- •4 weeks for prior vaginal hormonal products (rings, creams, gels) or
- •transdermal estrogen or estrogen/progestin products.
- •4 weeks for oral estradiol (e.g., micronized estradiol) or SERM products
- •(e.g., raloxifene).
- •8 weeks for prior oral conjugated (equine or synthetic) estrogen or
- •estrogen/progestin products or for prior intrauterine progestin therapy.
- •3 months for prior progestin implants or injectable estrogen.
- •6 months for prior estrogen pellet therapy or injectable progestin.
- •ii. Use of putative therapies for VMS relief (e.g., selective serotonin reuptake
- •inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs],
- •clonidine, gabapentin, tibolone, methyldopa, and phytoestrogens such as black
- •cohosh, and red clover) within the past 30 days or 5 half-lives (whichever is
- •longer) before the assessment of baseline VMS symptoms (half-lives will be
- •provided in the SPM). Use of non-medication treatments for VMS, such as
- •acupuncture and biofeedback.
- •iii. Use of weight loss drugs (e.g., phentermine, sibutramine, orlistat, rimonabant)
- •within 3 months of the first dose of investigational product.
- •iv. Use of pravastatin [Pravachol/Lipostat], rosuvastatin [Crestor], or pitavastatin
- •[Livalo] within 5 half-lives of the first dose of investigational product (note: halflives
- •will be provided in the SPM. Uses of other statins, for example simvastatin
- •[Zocor], atorvastatin [Lipitor], fluvastatin [Lescol], lovastatin [Mevacor] are
- •v. Use of bupropion, orphenadine [Norflex], cyclophosphamide, efavirenz,
- •ifosfamide, or methadone (because of the potential for GSK232802 to inhibit
- •CYP2B6), or use of paclitaxel, torsemide, amodiaquine, or repaglinide (because
- •of the potential for GSK232802 to inhibit CYP2C8).
- •vi. Women on a concurrent anti-depressant, anti-hypertensive, or lipid-lowering
- •therapy (except for medications specifically excluded above) may be included in
- •the study, as long as they have been stable on these medications for at least 1 month.
- •3. Use of investigational drug within the past 30 days or 5 half-lives (whichever is
- •longer) before the first dose of investigational product.
- •4. Uterine disease or medical condition including: Bi-layer endometrial thickness
- •greater than or equal to 5mm as determined by TVUS; presence of fibroids that
- •obscure evaluation of endometrium by TVUS; history of uterine cancer; evidence of
- •endometrial hyperplasia or cancer as assessed by endometrial biopsy before
- •enrollment (Note: if a subject has insufficient tissue for diagnosis at screening, but
- •endometrial thickness by TVUS is <5mm, she may still be eligible for study entry if
- •she meets the remaining inclusion/exclusion criteria); unexplained or unusual
- •endometrial bleeding; or uterine surgery (within the past 6 months). Evidence of
- •malignancy as assessed by cervical Pap smear.
- •5. History of breast or ovarian cancer.
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