Comparison of Ultra-low-dose Oral Versus Trans-dermal Hormone Therapy on Coagulation Activation and Metabolic Risk Factors for Cardiovascular Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Thrombin Generation IU/DL
研究概览
简要总结
Ultra-low-dose oral E2/D will have more beneficial effects than trans-dermal HRT on lipids and insulin resistance in postmenopausal women, whilst adverse effects on coagulation will be avoided.
详细描述
Following screening for eligibility, women will be studied at baseline and then randomized to one of two groups:
Group A administered Femoston Conti - oral oestradiol 17β 0.5 mg/dydrogesterone 2.5 mg daily for the duration of the treatment phase (24 weeks)
Group B administered ½ Evorel Conti patches - trans-dermal Estradiol 25 mcg/norethisterone acetate 85 mcg (½ Evorel Conti patches) daily for the duration of the treatment phase (24 weeks).
Studies will be repeated after 6 months of therapy at the follow up visit.
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
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy and postmenopausal woman who have had a normal ultrasound result
- •Aged 40 - 60 years
- •At least 1 year post last menstrual period (per participant report)
- •BMI 18 - 32
- •Normal mammogram within 2 years of study commencement
- •Continue on any concomitant medications without any change during the study give informed consent
排除标准
- •Estrogen or androgen therapy during preceding 3 months
- •Use of hormone implants during the preceding 12 months
- •Have received any medications which may interfere with the study (SSRI, antiandrogens,
- •PDE5 inhibitors, DHEA, SERMS)
- •Have a significant psychiatric disorder
- •Have a history of breast or oestrogen dependent cancer
- •Have diabetes, thrombo-embolic disorders (recent MI angina DVT varicose veins or recurrent DVT), cardiovascular disease, liver disease any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia
- •Untreated endometrial hyperplasia
- •Dubin-Johnson syndrome and Rotor syndrome
- •Undiagnosed vaginal bleeding
- •Women who have had a hysterectomy
研究组 & 干预措施
Femoston Conti 0.5mg/2.5mg
Ultra low dose, film-coated 17β-estradiol (as hemihydrate) 0.5mg & dydrogesterone 2.5 mg
Once a day
The duration is six months.
Drug intervention: Estradiol&DydrogesteronevsOestradiol&Norethisterone acetate
干预措施: Femoston Conti (Drug)
EVOREL® CONTI transdermal patches
EVOREL CONTI is a transdermal self adhesive patch which is 0.1 mm in thickness and each patch releases 50mcg of oestradiol and 170mcg of norethisterone acetate over 24 hours .
The Evorel Conti patch is cut in half and applied to the lower part of the body for 3.5 days (delivering approx 25mcg of oestradiol over 24 hours ) this is replaced every 3.5 days .
The duration is six months.
Drug intervention: Estradiol&DydrogesteronevsOestradiol&Norethisterone acetate
干预措施: EVOREL® CONTI (Drug)
结局指标
主要结局
Thrombin Generation IU/DL
时间窗: Six months
次要结局
- Factor V11(6 months)
- APC resistance(6 months)
- HDL(6 months)
- fibrinogen(6 months)
- triglycerides(6 months)
- LDL(6 months)
- D-Dimers(6 months)
- fasting glucose(6 months)
- Total cholesterol(6 months)
- fasting insulin(6 months)
- PAI-1 protein(6 months)