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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose of Klimadynon® | Experimental |
| |
| Medium dose of Klimadynon® | Experimental |
| |
| High dose of Klimadynon® | Experimental |
| |
| Oestrofeminal® | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose of Klimadynon® | Drug |
| ||
| Medium dose of Klimadynon® |
| Measure | Description | Time Frame |
|---|---|---|
| Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS) | baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of score of MRS items 7-10 and items 1-10 | baseline, week 12 | |
| Change of menopause index according to Kupperman | a 4 point numerical scale rating of 11 weighted menopause-related symptom complexes |
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Inclusion Criteria:
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:
In addition to other menopausal complaints the women must have hot flushes / outbreaks of sweating:
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"
Exclusion Criteria:
General criteria for exclusion:
Exclusion criteria based on conjugated estrogens or medroxyprogesterone:
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| ID | Term |
|---|---|
| C584106 | Klimadynon |
| D004966 | Estrogens, Conjugated (USP) |
| ID | Term |
|---|---|
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
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| Drug |
|
| High dose of Klimadynon® | Drug |
|
| Oestrofeminal® | Drug |
|
| Placebo | Drug |
|
| Baseline up to day 98 |
| Changes in daily frequency of menopausal lead symptoms | diary information | Up to day 105 |
| Changes from baseline in serum concentration of oestradiol-17ß | Up to day 98 |
| Changes from baseline in serum concentration of FSH | Up to day 98 |
| Changes from baseline in serum concentration of luteinising hormone | Up to day 98 |
| Changes from baseline in serum concentration of osteocalcin | Up to day 98 |
| 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 |
| Changes from baseline in serum concentration of cholesterol | 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 low density lipoproteins | Up to day 98 |
| Changes from baseline in serum concentration of triglycerides | 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 |
| Assessment of global efficacy evaluated by patient and investigator on a 4-point rating scale | At day 98 |
| Changes from baseline in thickness of endometrium | measured in millimeters, assessed by transvaginal ultrasonography | Baseline, day 84 |
| Diary information regarding frequency, duration and intensity of vaginal bleeding on treatment | Up to day 105 |
| Changes from baseline for mammography/ ultrasonography assessment of the breasts | Baseline, 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 |
| Changes from baseline in clinical laboratory including coagulation parameters | Baseline, day 56, day 98 |
| Assessment for incidence of withdrawal bleeding upon peroral gestagen administration | At day 105 |
| Assessment of global tolerability evaluated by patient and investigator (4-point rating scale) | At day 98 |
| Change in scores of major climacteric complaints (MRS items 1, 4, 9, 10) | baseline, week 12 |
| Change in scores of somatic complaints (MRS items 1, 2, 8, 9, 10) | baseline, week 12 |
| Changes from baseline in body weight | Baseline up to day 98 |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |