HealthyPhase 4NCT00335218
Fat Distribution in Healthy Early Postmenopausal Women
A Phase 4 study testing Climodien / Lafamme (BAY86-5027) in people with Healthy and Postmenopause, run by Bayer at 3 sites in Austria.
Trial summary
The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 48 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Postmenopause
- What is being tested?
- Climodien / Lafamme (BAY86-5027)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 3 sitesAustria
- Study dates
- Jul 2002to Aug 2004
- Phase
- Phase 4
- 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 48 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy early postmenopausal women
- BMI between 25 and 30
Who cannot join
- Contra-indication(s) for hormone treatment
- Metabolic diseases
- Concomitant medication with influence on lipid metabolism
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Study site
Vienna, State of Vienna, 1090
Study site
Vienna, 1060
Study site
Vienna, 1200
About this study
Official title: A Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled, Two-arm, Phase IV Study to Investigate the Influence of a Continuous Combined Estrogen-progestin Regimen Containing 2 mg Estradiol Valerate and 2 mg Dienogest (Climodien® / Lafamme®) on the Fat Distribution in Otherwise Healthy Early Postmenopausal Women
The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Healthy, Postmenopause
- Being tested
- Climodien / Lafamme (BAY86-5027), Placebo
- Keywords
- Early postmenopausal state, Climacteric symptoms, Hormone replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Climodien / Lafamme (BAY86-5027)Drug
1 tablet daily (2 mg EV + 2 mg DNG)
PlaceboDrug
1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Climodien / Lafamme (BAY86-5027) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual relative change of abdominal visceral fat measured by magnetic resonance imaging
Measured: Baseline and after 24 weeks of treatment
Secondary outcomes (2)
Parameters of body composition and lipid metabolism
Measured: Baseline and after 24 weeks of treatment
Adverse events collection
Measured: During whole study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startJul 2002
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335218
- Sponsor's protocol ID
- 91161
- Other IDs
- 306387
- Status last verified
- Dec 2014
- First submitted
- 24 Feb 2006
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled, Two-arm, Phase IV Study to Investigate the Influence of a Continuous Combined Estrogen-progestin Regimen Containing 2 mg Estradiol Valerate and 2 mg Dienogest (Climodien® / Lafamme®) on the Fat Distribution in Otherwise Healthy Early Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00335218
- Acronym / sponsor ID
- 91161
- Conditions
- Healthy, Postmenopause
- Keywords
- Early postmenopausal state, Climacteric symptoms, Hormone replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Aug 2004 (actual)
- First posted
- 9 Jun 2006 (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.
The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Climodien / Lafamme (BAY86-5027) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 48 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy early postmenopausal women
- BMI between 25 and 30
Key exclusion criteria (3 listed)
- Contra-indication(s) for hormone treatment
- Metabolic diseases
- Concomitant medication with influence on lipid metabolism
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 |
|---|---|---|
| Climodien / Lafamme (BAY86-5027)1 tablet daily (2 mg EV + 2 mg DNG) | Drug | Arm 1 |
| Placebo1 tablet daily | Drug | Arm 2 |
Primary outcome
Individual relative change of abdominal visceral fat measured by magnetic resonance imaging
Time frame: Baseline and after 24 weeks of treatment
2 secondary outcomes
Parameters of body composition and lipid metabolism
Time frame: Baseline and after 24 weeks of treatment
Adverse events collection
Time frame: During whole study period
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 30 Dec 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.
Bayer Study Director study director
Bayer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Climodien / Lafamme (BAY86-5027) in people with Healthy and Postmenopause, run by Bayer at 3 sites in Austria.
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 2 inclusion and 3 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 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Individual relative change of abdominal visceral fat measured by magnetic resonance imaging (time frame: Baseline and after 24 weeks of treatment). 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 30 Dec 2014.