Klimadynon® in Comparison to Conjugated Oestrogens in Women Suffering From Menopausal Complaints (NCT02184364) | Clinical Trial Compass
CompletedPhase 3
Klimadynon® in Comparison to Conjugated Oestrogens in Women Suffering From Menopausal Complaints
161 participantsStarted 1998-11
Plain-language 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
Who can participate
Age range40 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 menstru…
What they're measuring
1
Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS)