MenopausePhase 3NCT02184364
Klimadynon® in Comparison to Conjugated Oestrogens in Women Suffering From Menopausal Complaints
A Phase 3 study testing Low dose of Klimadynon®, Medium dose of Klimadynon® and High dose of Klimadynon® in people with Menopause, run by Boehringer Ingelheim.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Low dose of Klimadynon®, Medium dose of Klimadynon® and High dose of Klimadynon®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Nov 1998to Sep 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
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- 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"
Who cannot join
- 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)
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- 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
About this study
Official title: 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
- Conditions
- Menopause
- Being tested
- Low dose of Klimadynon®, Medium dose of Klimadynon®, High dose of Klimadynon®, Oestrofeminal®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of Klimadynon®Drug
Medium dose of Klimadynon®Drug
High dose of Klimadynon®Drug
Oestrofeminal®Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose of Klimadynon® | Experimental | Not described Receives: Drug: Low dose of Klimadynon® |
| Medium dose of Klimadynon® | Experimental | Not described Receives: Drug: Medium dose of Klimadynon® |
| High dose of Klimadynon® | Experimental | Not described Receives: Drug: High dose of Klimadynon® |
| Oestrofeminal® | Active comparator | Not described Receives: Drug: Oestrofeminal® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS)
Measured: baseline, week 12
Secondary outcomes (27)
Change of score of MRS items 7-10 and items 1-10
Measured: baseline, week 12
Change of menopause index according to Kupperman
a 4 point numerical scale rating of 11 weighted menopause-related symptom complexes
Measured: Baseline up to day 98
Changes in daily frequency of menopausal lead symptoms
diary information
Measured: Up to day 105
Changes from baseline in serum concentration of oestradiol-17ß
Measured: Up to day 98
Changes from baseline in serum concentration of FSH
Measured: Up to day 98
Changes from baseline in serum concentration of luteinising hormone
Measured: Up to day 98
Changes from baseline in serum concentration of osteocalcin
Measured: Up to day 98
Changes from baseline in serum concentration of ß-CrossLaps
Measured: Up to day 98
Changes from baseline in serum concentration of bone specific alkaline phosphatase
Measured: Up to day 98
Changes from baseline in serum concentration of cholesterol
Measured: Up to day 98
Changes from baseline in serum concentration of high density lipoproteins
Measured: Up to day 98
Changes from baseline in serum concentration of low density lipoproteins
Measured: Up to day 98
Changes from baseline in serum concentration of triglycerides
Measured: Up to day 98
Changes from baseline in serum concentration of glucose
Measured: Up to day 98
Changes from baseline in maturity index of the vaginal epithelium
Measured: Baseline, day 84
Assessment of global efficacy evaluated by patient and investigator on a 4-point rating scale
Measured: At day 98
Changes from baseline in thickness of endometrium
measured in millimeters, assessed by transvaginal ultrasonography
Measured: Baseline, day 84
Diary information regarding frequency, duration and intensity of vaginal bleeding on treatment
Measured: Up to day 105
Changes from baseline for mammography/ ultrasonography assessment of the breasts
Measured: Baseline, day 98
Changes from baseline in vital signs (blood pressure, heart rate)
Measured: Baseline up to day 98
Number of patients with adverse events
Measured: Up to day 105
Changes from baseline in clinical laboratory including coagulation parameters
Measured: Baseline, day 56, day 98
Assessment for incidence of withdrawal bleeding upon peroral gestagen administration
Measured: At day 105
Assessment of global tolerability evaluated by patient and investigator (4-point rating scale)
Measured: At day 98
Change in scores of major climacteric complaints (MRS items 1, 4, 9, 10)
Measured: baseline, week 12
Change in scores of somatic complaints (MRS items 1, 2, 8, 9, 10)
Measured: baseline, week 12
Changes from baseline in body weight
Measured: Baseline up to day 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startNov 1998
- Primary completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184364
- Sponsor's protocol ID
- 563.1
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Dose/Response Study Comparing Klimadynon® With Conjugated Oestrogens in Women Suffering From Menopausal Complaints
- ClinicalTrials.gov ID
- NCT02184364
- Acronym / sponsor ID
- 563.1
- Conditions
- Menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Sep 2000 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low dose of Klimadynon® | Experimental | Drug: Low dose of Klimadynon® |
| Medium dose of Klimadynon® | Experimental | Drug: Medium dose of Klimadynon® |
| High dose of Klimadynon® | Experimental | Drug: High dose of Klimadynon® |
| Oestrofeminal® | Active comparator | Drug: Oestrofeminal® |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- In addition to other menopausal complaints the women must have hot flushes / outbreaks of sweating:
- 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
Key exclusion criteria (36 listed)
- General criteria for exclusion:
- Exclusion criteria based on conjugated estrogens or medroxyprogesterone:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose of Klimadynon® | Drug | Low dose of Klimadynon® |
| Medium dose of Klimadynon® | Drug | Medium dose of Klimadynon® |
| High dose of Klimadynon® | Drug | High dose of Klimadynon® |
| Oestrofeminal® | Drug | Oestrofeminal® |
| Placebo | Drug | Placebo |
Primary outcome
Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS)
Time frame: baseline, week 12
27 secondary outcomes
Change of score of MRS items 7-10 and items 1-10
Time frame: baseline, week 12
Change of menopause index according to Kupperman
Time frame: Baseline up to day 98
Changes in daily frequency of menopausal lead symptoms
Time frame: Up to day 105
Changes from baseline in serum concentration of oestradiol-17ß
Time frame: Up to day 98
Changes from baseline in serum concentration of FSH
Time frame: Up to day 98
Changes from baseline in serum concentration of luteinising hormone
Time frame: Up to day 98
Changes from baseline in serum concentration of osteocalcin
Time frame: Up to day 98
Changes from baseline in serum concentration of ß-CrossLaps
Time frame: Up to day 98
Changes from baseline in serum concentration of bone specific alkaline phosphatase
Time frame: Up to day 98
Changes from baseline in serum concentration of cholesterol
Time frame: Up to day 98
Changes from baseline in serum concentration of high density lipoproteins
Time frame: Up to day 98
Changes from baseline in serum concentration of low density lipoproteins
Time frame: Up to day 98
Changes from baseline in serum concentration of triglycerides
Time frame: Up to day 98
Changes from baseline in serum concentration of glucose
Time frame: Up to day 98
Changes from baseline in maturity index of the vaginal epithelium
Time frame: Baseline, day 84
Assessment of global efficacy evaluated by patient and investigator on a 4-point rating scale
Time frame: At day 98
Changes from baseline in thickness of endometrium
Time frame: Baseline, day 84
Diary information regarding frequency, duration and intensity of vaginal bleeding on treatment
Time frame: Up to day 105
Changes from baseline for mammography/ ultrasonography assessment of the breasts
Time frame: Baseline, day 98
Changes from baseline in vital signs (blood pressure, heart rate)
Time frame: Baseline up to day 98
Number of patients with adverse events
Time frame: Up to day 105
Changes from baseline in clinical laboratory including coagulation parameters
Time frame: Baseline, day 56, day 98
Assessment for incidence of withdrawal bleeding upon peroral gestagen administration
Time frame: At day 105
Assessment of global tolerability evaluated by patient and investigator (4-point rating scale)
Time frame: At day 98
Change in scores of major climacteric complaints (MRS items 1, 4, 9, 10)
Time frame: baseline, week 12
Change in scores of somatic complaints (MRS items 1, 2, 8, 9, 10)
Time frame: baseline, week 12
Changes from baseline in body weight
Time frame: Baseline up to day 98
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low dose of Klimadynon®, Medium dose of Klimadynon® and High dose of Klimadynon® in people with Menopause, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of score in menopause-related symptom categories of the modified menopausal rating scale (MRS) (time frame: baseline, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.