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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
161
Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS)
Time frame: baseline, week 12
Change of score of MRS items 7-10 and items 1-10
Time frame: baseline, week 12
Change of menopause index according to Kupperman
a 4 point numerical scale rating of 11 weighted menopause-related symptom complexes
Time frame: Baseline up to day 98
Changes in daily frequency of menopausal lead symptoms
diary information
Time frame: Up to day 105
Changes from baseline in serum concentration of oestradiol-17ß
Time frame: Up to day 98
Changes from baseline in serum concentration of FSH
Time frame: Up to day 98
Changes from baseline in serum concentration of luteinising hormone
Time frame: Up to day 98
Changes from baseline in serum concentration of osteocalcin
Time frame: Up to day 98
Changes from baseline in serum concentration of ß-CrossLaps
Time frame: Up to day 98
Changes from baseline in serum concentration of bone specific alkaline phosphatase
Time frame: Up to day 98
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Changes from baseline in serum concentration of cholesterol
Time frame: Up to day 98
Changes from baseline in serum concentration of high density lipoproteins
Time frame: Up to day 98
Changes from baseline in serum concentration of low density lipoproteins
Time frame: Up to day 98
Changes from baseline in serum concentration of triglycerides
Time frame: Up to day 98
Changes from baseline in serum concentration of glucose
Time frame: Up to day 98
Changes from baseline in maturity index of the vaginal epithelium
Time frame: Baseline, day 84
Assessment of global efficacy evaluated by patient and investigator on a 4-point rating scale
Time frame: At day 98
Changes from baseline in thickness of endometrium
measured in millimeters, assessed by transvaginal ultrasonography
Time frame: Baseline, day 84
Diary information regarding frequency, duration and intensity of vaginal bleeding on treatment
Time frame: Up to day 105
Changes from baseline for mammography/ ultrasonography assessment of the breasts
Time frame: Baseline, day 98
Changes from baseline in vital signs (blood pressure, heart rate)
Time frame: Baseline up to day 98
Number of patients with adverse events
Time frame: Up to day 105
Changes from baseline in clinical laboratory including coagulation parameters
Time frame: Baseline, day 56, day 98
Assessment for incidence of withdrawal bleeding upon peroral gestagen administration
Time frame: At day 105
Assessment of global tolerability evaluated by patient and investigator (4-point rating scale)
Time frame: At day 98
Change in scores of major climacteric complaints (MRS items 1, 4, 9, 10)
Time frame: baseline, week 12
Change in scores of somatic complaints (MRS items 1, 2, 8, 9, 10)
Time frame: baseline, week 12
Changes from baseline in body weight
Time frame: Baseline up to day 98