PostmenopauseNCT00913926
Effects of Wellnara on Climacteric Symptoms
An observational study of Postmenopause, run by Bayer at 1 site in Germany.
Trial summary
Aim of this NIS is to obtain further information on efficacy, tolerability, and acceptance of Wellnara in a large user population under the conditions of routine medical practice. Furthermore, any adverse drug reactions will be recorded in a large user population under the conditions of medical routine. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopause
- What is being tested?
- E2/LNG oral (Wellnara, BAY86-5029)
- Type of treatment
- Pill or oral medicine
- How many people
- 749 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to May 2009
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target population of this study are women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist. The study is expected to collect data of up to 2,400 women in about 700 gynecological practices in Germany.
Who may be able to join
- Women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist
Who cannot join
- Limited to the criteria listed in the expert information as contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Non-interventional Study on Efficacy, Tolerability, and Acceptance of Wellnara Containing 1.03 mg Estradiol Hemihydrate (Equivalent to 1 mg Estradiol) and 0.04 mg Levonorgestrel for Treatment of Hormone Deficiency Symptoms in Postmenopausal Women During 6 Cycles of 28 Days.
Aim of this NIS is to obtain further information on efficacy, tolerability, and acceptance of Wellnara in a large user population under the conditions of routine medical practice. Furthermore, any adverse drug reactions will be recorded in a large user population under the conditions of medical routine. To investigate the efficacy of Wellnara, patients will fill in a questionnaire, the so-called Menopause Rating Scale (MRS II). Further, the effects of treatment on skin and hair will be evaluated by the investigator. Patients will assess treatment effects on their sexual life. Safety parameters include monitoring of vaginal bleeding, measurement of blood pressure and body weight, and - as far as routinely used in the practice - calculation of waist-hip-ratio. Any relevant additional information related to adverse drug reactions will also be documented.
- Conditions
- Postmenopause
- Being tested
- E2/LNG oral (Wellnara, BAY86-5029)
- Keywords
- Climacteric symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2/LNG oral (Wellnara, BAY86-5029)Drug
Patients in daily life treatment receiving Wellnara according to local drug information.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: E2/LNG oral (Wellnara, BAY86-5029) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint in the observation of efficacy concerning climacteric complaints is the change in Menopause Rating Scale (MRS II) in relation to the status immediately before starting treatment (Baseline).
Measured: At Baseline, after 3 months, after 6 months
Secondary outcomes (8)
Effects on climacteric-related skin, hair, and sexual problems
Measured: At Baseline, after 3 months, after 6 months
Subjective assessment of efficacy
Measured: After end of study
Body weight
Measured: At Baseline, after 3 months, after 6 months
Blood Pressure
Measured: At baseline, end of Study
Waist-hip-ratio (as far as routinely used in the practice)
Measured: At baseline, after 6 months
Occurrence of vaginal bleeding
Measured: After 3 months, after 6 months
Subjective assessment of tolerability
Measured: End of study
Adverse drug reactions
Measured: During the whole study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startSep 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 749 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913926
- Sponsor's protocol ID
- 14575
- Other IDs
- WN0810DE
- Status last verified
- Apr 2015
- First submitted
- 3 Jun 2009
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Non-interventional Study on Efficacy, Tolerability, and Acceptance of Wellnara Containing 1.03 mg Estradiol Hemihydrate (Equivalent to 1 mg Estradiol) and 0.04 mg Levonorgestrel for Treatment of Hormone Deficiency Symptoms in Postmenopausal Women During 6 Cycles of 28 Days.
- ClinicalTrials.gov ID
- NCT00913926
- Acronym / sponsor ID
- 14575
- Conditions
- Postmenopause
- Keywords
- Climacteric symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 749 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Jun 2009 (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.
Aim of this NIS is to obtain further information on efficacy, tolerability, and acceptance of Wellnara in a large user population under the conditions of routine medical practice. Furthermore, any adverse drug reactions will be recorded in a large user population under the conditions of medical routine. To investigate the efficacy of Wellnara, patients will fill in a questionnaire, the so-called Menopause Rating Scale (MRS II). Further, the effects of treatment on skin and hair will be evaluated by the investigator. Patients will assess treatment effects on their sexual life. Safety parameters include monitoring of vaginal bleeding, measurement of blood pressure and body weight, and - as far as routinely used in the practice - calculation of waist-hip-ratio. Any relevant additional information related to adverse drug reactions will also be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: E2/LNG oral (Wellnara, BAY86-5029) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population of this study are women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist. The study is expected to collect data of up to 2,400 women in about 700 gynecological practices in Germany.
Key inclusion criteria (1 listed)
- Women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist
Key exclusion criteria (1 listed)
- Limited to the criteria listed in the expert information as contraindications
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 |
|---|---|---|
| E2/LNG oral (Wellnara, BAY86-5029)Patients in daily life treatment receiving Wellnara according to local drug information. | Drug | Group 1 |
Primary outcome
Primary endpoint in the observation of efficacy concerning climacteric complaints is the change in Menopause Rating Scale (MRS II) in relation to the status immediately before starting treatment (Baseline).
Time frame: At Baseline, after 3 months, after 6 months
8 secondary outcomes
Effects on climacteric-related skin, hair, and sexual problems
Time frame: At Baseline, after 3 months, after 6 months
Subjective assessment of efficacy
Time frame: After end of study
Body weight
Time frame: At Baseline, after 3 months, after 6 months
Blood Pressure
Time frame: At baseline, end of Study
Waist-hip-ratio (as far as routinely used in the practice)
Time frame: At baseline, after 6 months
Occurrence of vaginal bleeding
Time frame: After 3 months, after 6 months
Subjective assessment of tolerability
Time frame: End of study
Adverse drug reactions
Time frame: During the whole study
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 22 Apr 2015.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopause, run by Bayer at 1 site in Germany.
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 1 inclusion and 1 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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Primary endpoint in the observation of efficacy concerning climacteric complaints is the change in Menopause Rating Scale (MRS II) in relation to the status immediately before starting treatment (Baseline). (time frame: At Baseline, after 3 months, after 6 months). 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 22 Apr 2015.