Klimadynon® in Comparison to Conjugated Oestrogens in Women Suffering From Menopausal Complaints

NCT ID: NCT02184364

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-11-30

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 mg, 75 mg or 150 mg plant material on menopause-related neurovegetative and mental complaints

Conditions

Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low dose of Klimadynon®

Group Type: EXPERIMENTAL

Low dose of Klimadynon®

Intervention Type: DRUG

Medium dose of Klimadynon®

Group Type: EXPERIMENTAL

Medium dose of Klimadynon®

Intervention Type: DRUG

High dose of Klimadynon®

Group Type: EXPERIMENTAL

High dose of Klimadynon®

Intervention Type: DRUG

Oestrofeminal®

Group Type: ACTIVE_COMPARATOR

Oestrofeminal®

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Low dose of Klimadynon®

Intervention Type: DRUG

Medium dose of Klimadynon®

Intervention Type: DRUG

High dose of Klimadynon®

Intervention Type: DRUG

Oestrofeminal®

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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"

• 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

• 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

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

563.1

Identifier Type: -

Identifier Source: org_study_id