临床试验/NCT00184795

NCT00184795已完成3 期

A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 576 人开始时间: 2004年5月28日最近更新: 2017年2月23日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 576
试验地点: 1
主要终点: Change in mean number of moderate to severe hot flushes per week

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 45 Years 至 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Postmenopausal status
•Subject should have had a minimum of 7 moderate to severe hot flushes per day, or a minimum of 50 moderate to severe hot flushes per week, during the last 2 weeks of the run-in (screening) period.
•Subject with an intact uterus

排除标准

•In accordance with existing labelling for estrogen/progestogen combinations
•Body Mass Index (BMI) > 35.0 kg/m2
•Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
•Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to influence estrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepin

研究组 & 干预措施

ALD 0.1

Experimental

干预措施: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) (Drug)

ALD 0.25

Experimental

干预措施: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) (Drug)

Placebo

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Change in mean number of moderate to severe hot flushes per week

时间窗: At week 8

次要结局

Urogenital symptoms(Week 0; week 24)
Vaginal cytology and pH(Week 0; week 24)
Bleeding profile(Week 0; week 24)
Adverse Events(Week 0; week 24)
Menopausal symptoms and quality of life (Greene Climacteric Scale)(Week 0; week 24)
Hot flush weekly weighted score(Week 0; week 24)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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