klimadynon® in comparison to conjugated oestrogens in women suffering from menopausal complaints

Conditions: Menopause

Summary: 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


Eligibility criteria:
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: * 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" exclusion criteria: * 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