MenopauseNCT01487304
Impact of Professional Societies' Recommendations on Practical Use of Hormone Replacement Therapy
An observational study of Menopause and Hormone Replacement Therapy, Post-Menopausal, run by Novo Nordisk A/S at 1 site in Czechia.
Trial summary
This study is conducted in Europe. The aim of this study is to verify the therapeutic effects of low-dose hormone replacement therapy (HRT) in female patients over adequately long time period in normal clinical practice conditions in the Czech Republic. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Menopause, Hormone Replacement Therapy, Post-Menopausal
- What is being tested?
- Marketed low dose hormone replacement therapy
- How many people
- 3,760 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2005to Jun 2006
- 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: Post-menopausal women suffering from climacteric symptoms who could benefit a switch from standard therapy to low dose therapy at the discretion of the individual physician
Who may be able to join
- Post-menopausal
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Professional Societies Recommendations on Practical Use of Hormone Replacement Therapy - Project "WOMAN 2005"
This study is conducted in Europe. The aim of this study is to verify the therapeutic effects of low-dose hormone replacement therapy (HRT) in female patients over adequately long time period in normal clinical practice conditions in the Czech Republic.
- Being tested
- Marketed low dose hormone replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed low dose hormone replacement therapyDrug
A low dose of marketed HRT products prescribed at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Low dose HRT | Not described Receives: Drug: Marketed low dose hormone replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast tenderness
Secondary outcomes (1)
Patient treatment satisfaction after switch to low dose HRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startApr 2005
- Primary completionJun 2006
- Study completionJun 2006
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 Novo Nordisk A/SThe 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
- 3,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487304
- Sponsor's protocol ID
- KLIM-1937
- Status last verified
- Oct 2016
- First submitted
- 5 Dec 2011
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Professional Societies Recommendations on Practical Use of Hormone Replacement Therapy - Project "WOMAN 2005"
- ClinicalTrials.gov ID
- NCT01487304
- Acronym / sponsor ID
- KLIM-1937
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,760 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 7 Dec 2011 (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.
This study is conducted in Europe. The aim of this study is to verify the therapeutic effects of low-dose hormone replacement therapy (HRT) in female patients over adequately long time period in normal clinical practice conditions in the Czech Republic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose HRT | – | Drug: Marketed low dose hormone replacement therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Post-menopausal women suffering from climacteric symptoms who could benefit a switch from standard therapy to low dose therapy at the discretion of the individual physician
Key inclusion criteria (1 listed)
- Post-menopausal
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Marketed low dose hormone replacement therapyA low dose of marketed HRT products prescribed at the discretion of the treating physician | Drug | Low dose HRT |
Primary outcome
Breast tenderness
1 secondary outcome
Patient treatment satisfaction after switch to low dose HRT
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 17 Oct 2016.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 Menopause and Hormone Replacement Therapy, Post-Menopausal, run by Novo Nordisk A/S at 1 site in Czechia.
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 0 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 17 Oct 2016. 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 Czechia. 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?
Breast tenderness. 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 17 Oct 2016.