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

July 11, 2014 updated by: Boehringer Ingelheim

Double-blind Dose/Response Study Comparing Klimadynon® With Conjugated Oestrogens in Women Suffering From Menopausal Complaints

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Low dose of Klimadynon®
Drug: Low dose of Klimadynon®
Experimental: Medium dose of Klimadynon®
Drug: Medium dose of Klimadynon®
Experimental: High dose of Klimadynon®
Drug: High dose of Klimadynon®
Active Comparator: Oestrofeminal®
Drug: Oestrofeminal®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS)
Time Frame: baseline, week 12
baseline, week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of score of MRS items 7-10 and items 1-10
Time Frame: baseline, week 12
baseline, week 12
Change of menopause index according to Kupperman
Time Frame: Baseline up to day 98
a 4 point numerical scale rating of 11 weighted menopause-related symptom complexes
Baseline up to day 98
Changes in daily frequency of menopausal lead symptoms
Time Frame: Up to day 105
diary information
Up to day 105
Changes from baseline in serum concentration of oestradiol-17ß
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of FSH
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of luteinising hormone
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of osteocalcin
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of ß-CrossLaps
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of bone specific alkaline phosphatase
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of cholesterol
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of high density lipoproteins
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of low density lipoproteins
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of triglycerides
Time Frame: Up to day 98
Up to day 98
Changes from baseline in serum concentration of glucose
Time Frame: Up to day 98
Up to day 98
Changes from baseline in maturity index of the vaginal epithelium
Time Frame: Baseline, day 84
Baseline, day 84
Assessment of global efficacy evaluated by patient and investigator on a 4-point rating scale
Time Frame: At day 98
At day 98
Changes from baseline in thickness of endometrium
Time Frame: Baseline, day 84
measured in millimeters, assessed by transvaginal ultrasonography
Baseline, day 84
Diary information regarding frequency, duration and intensity of vaginal bleeding on treatment
Time Frame: Up to day 105
Up to day 105
Changes from baseline for mammography/ ultrasonography assessment of the breasts
Time Frame: Baseline, day 98
Baseline, day 98
Changes from baseline in vital signs (blood pressure, heart rate)
Time Frame: Baseline up to day 98
Baseline up to day 98
Number of patients with adverse events
Time Frame: Up to day 105
Up to day 105
Changes from baseline in clinical laboratory including coagulation parameters
Time Frame: Baseline, day 56, day 98
Baseline, day 56, day 98
Assessment for incidence of withdrawal bleeding upon peroral gestagen administration
Time Frame: At day 105
At day 105
Assessment of global tolerability evaluated by patient and investigator (4-point rating scale)
Time Frame: At day 98
At day 98
Change in scores of major climacteric complaints (MRS items 1, 4, 9, 10)
Time Frame: baseline, week 12
baseline, week 12
Change in scores of somatic complaints (MRS items 1, 2, 8, 9, 10)
Time Frame: baseline, week 12
baseline, week 12
Changes from baseline in body weight
Time Frame: Baseline up to day 98
Baseline up to day 98

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2000

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 563.1

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