Status:
COMPLETED
Klimadynon® in Comparison to Conjugated Oestrogens in Women Suffering From Menopausal Complaints
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Menopause
Eligibility:
FEMALE
40-60 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT02184364
Start Date
November 1 1998
Last Update
July 14 2014
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