NCT02184364已完成3 期
Double-blind Dose/Response Study Comparing Klimadynon® With Conjugated Oestrogens in Women Suffering From Menopausal Complaints
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS)
研究概览
简要总结
To investigate, relative to placebo and conjugated oestrogens, the efficacy, safety and tolerability of a 12 weeks peroral treatment twice daily with a cimicifuga racemosa extract corresponding to 20 mg, 75 mg or 150 mg plant material on menopause-related neurovegetative and mental complaints
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
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Only postmenopausal (amenorrhea for 6 months at least) women may be enrolled in the study
- •Women after ovariectomy may also be enrolled if surgery was carried out at least 6 months prior to the enrollment. Only women between the age of 40 and 60 may be included
- •2 weeks (control -1, week -2, day -14) before the beginning of the treatment the following hormone values must have been analyzed:
- •estradiol-17ß ≤ 0.15 nmol/l corresponding to ≤ 40 pg/ml and follicle stimulating hormone (FSH) ≥ 25 milliunits per milliliter (mU/ml)
- •These hormone analyses must be carried out at the competent local laboratory
- •In addition to other menopausal complaints the women must have hot flushes / outbreaks of sweating:
- •Diary: During the "run-in period" daily ≥ 3 hot flushes / outbreaks of sweating
- •Modified Menopause Rating Scale, 1st item twofold (week -2 and 0) ≥ 0.3
- •A sum score taken twice from the modified (only items 1 - 6) Menopause Rating Scale within 2 weeks (week - 1 and 0) before the beginning of treatment must be ≥ 1.7
- •In case of a pretreatment with estrogen a wash-out phase of 6 weeks is necessary in case of oral or transdermal administration. After the 4th week of wash-out the patient may be included in the "run-in period"
排除标准
- •General criteria for exclusion:
- •Non-responder (= no therapeutic success) under a pretreatment with estrogen
- •Amenorrhea for < 6 months
- •In case of an estrogen pretreatment last menstruation (menopause) > 3 years earlier
- •Sum score of the modified Menopause Rating Scale (items 1 - 6) during the "run-in period" twice (week -2 and 0) < 1.7
- •No hot flushes / outbreaks of sweating (see Inclusion criteria)
- •At one of the appointments of the "run-in period" (week -2 and 0) more than one question of items 1 - 6 of the modified Menopause Rating Scale (MMRS) not answered
- •During the "run-in period" at the appointment week -2: estradiol-17ß > 40 pg/ml corresponding to > 0.15 nmol/l and FSH < 25 mU/ml
- •Condition after hysterectomy
- •Simultaneous ingestion of estrogen-containing products in addition to the test products
- •Any addition ingestion of psychotropic drugs, antidepressants and sleeping aids (hypnotics / sedatives)
- •Treatment with another study drug in the 2 months preceding the beginning of the study
- •Considerable overweight (exceeding the target body weight [height in cm minus 100] by more than 30%)
- •Poor general condition
- •Alcohol or drug abuse
- •Poor compliance
- •Exclusion criteria based on conjugated estrogens or medroxyprogesterone:
- •Any contraindication for estrogen
- •Unresolved genital bleeding
- •Suspicion / existence of estrogen-dependent mammary carcinoma (mammography and/or endometrial carcinoma)
- •Endometriosis
- •Endometrial hyperplasia (including hyperplastic polypoid endometrium, which has not yet reached the stage of a glandular cystic hyperplasia)
- •Thickness of endometrium > 5 mm
- •Existing thromboembolism or thromboembolism in the past
- •Phlebitis in the past 2 years or actually existing
- •Acute or chronic hepatic lesion (aspartate transaminase and/or alanine transaminase and/or gamma glutamyl transferase twice the normal range)
- •Metabolic disorders of bile pigments (Dubin-Johnson's syndrome, Rotor syndrome, pregnancy icterus with/without pruritus in previous pregnancy)
- •Sickle cell anemia
- •Clinically relevant hypertriglyceridemia or hypercholesterolemia
- •Heart attack in the past
- •Severe varicosis
- •Known sensitivity to medroxyprogesterone
- •Case history of anaphylactic reaction
- •Any neoplasm at the genitals
- •Case history of antidepressant treatment
- •Diabetes mellitus with or without treatment
研究组 & 干预措施
Medium dose of Klimadynon®
Experimental
干预措施: Medium dose of Klimadynon® (Drug)
High dose of Klimadynon®
Experimental
干预措施: High dose of Klimadynon® (Drug)
Low dose of Klimadynon®
Experimental
干预措施: Low dose of Klimadynon® (Drug)
Oestrofeminal®
Active Comparator
干预措施: Oestrofeminal® (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS)
时间窗: baseline, week 12
次要结局
- Changes from baseline in serum concentration of oestradiol-17ß(Up to day 98)
- Changes from baseline in serum concentration of luteinising hormone(Up to day 98)
- Changes from baseline in serum concentration of high density lipoproteins(Up to day 98)
- Changes from baseline in serum concentration of glucose(Up to day 98)
- Changes from baseline in maturity index of the vaginal epithelium(Baseline, day 84)
- Changes from baseline in clinical laboratory including coagulation parameters(Baseline, day 56, day 98)
- Change in scores of somatic complaints (MRS items 1, 2, 8, 9, 10)(baseline, week 12)
- Change in scores of major climacteric complaints (MRS items 1, 4, 9, 10)(baseline, week 12)
- Changes in daily frequency of menopausal lead symptoms(Up to day 105)
- Changes from baseline in serum concentration of ß-CrossLaps(Up to day 98)
- Changes from baseline in serum concentration of bone specific alkaline phosphatase(Up to day 98)
- Assessment of global efficacy evaluated by patient and investigator on a 4-point rating scale(At day 98)
- Changes from baseline in vital signs (blood pressure, heart rate)(Baseline up to day 98)
- Number of patients with adverse events(Up to day 105)
- Assessment for incidence of withdrawal bleeding upon peroral gestagen administration(At day 105)
- Changes from baseline in serum concentration of FSH(Up to day 98)
- Changes from baseline in serum concentration of low density lipoproteins(Up to day 98)
- Changes from baseline for mammography/ ultrasonography assessment of the breasts(Baseline, day 98)
- Assessment of global tolerability evaluated by patient and investigator (4-point rating scale)(At day 98)
- Change of score of MRS items 7-10 and items 1-10(baseline, week 12)
- Change of menopause index according to Kupperman(Baseline up to day 98)
- Changes from baseline in serum concentration of osteocalcin(Up to day 98)
- Changes from baseline in serum concentration of cholesterol(Up to day 98)
- Changes from baseline in thickness of endometrium(Baseline, day 84)
- Diary information regarding frequency, duration and intensity of vaginal bleeding on treatment(Up to day 105)
- Changes from baseline in body weight(Baseline up to day 98)
- Changes from baseline in serum concentration of triglycerides(Up to day 98)
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