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 range
40 Years – 60 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS)