Postmenopausal PeriodAngeliq rPMSNCT01064453
Angeliq Regulatory Post Marketing Surveillance
An observational study of Postmenopausal Period and Osteoporosis, Postmenopausal, run by Bayer at 1 site in South Korea.
Trial summary
Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-interventional , prospective, multi-center study.Target number of patients is 4500. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopausal Period, Osteoporosis, Postmenopausal
- What is being tested?
- E2/DRSP (Angeliq, BAY86-4891)
- Type of treatment
- Pill or oral medicine
- How many people
- 4,078 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2007to Dec 2012
- 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: Korean women who take Angeliq for postmenopausal symptoms or/and prevention of osteoporosis
Who may be able to join
- Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause
- Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis
Who cannot join
- Undiagnosed genital bleeding
- Known, past or suspected cancer of the breast
- Known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer)
- Untreated endometrial hyperplasia
- Previous idiopathic or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism)
- Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
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- Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
- Porphyria
- Severe renal insufficiency or acute renal failure
- Known hypersensitivity to the active substances or to any of the excipients
Trial locations and contacts
1 site in 1 country.
About this study
Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-interventional , prospective, multi-center study.Target number of patients is 4500.
- Being tested
- E2/DRSP (Angeliq, BAY86-4891)
- Keywords
- Menopause, Menopausal symptoms, Prevention of osteoporosis in menopausal women, Estrogen deficiency symptoms, Hormone replacement therapy
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2/DRSP (Angeliq, BAY86-4891)Drug
Take one tablet daily, continuously
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: E2/DRSP (Angeliq, BAY86-4891) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event collection
Measured: At each visit of patient during observational period (6 months)
Secondary outcomes (1)
Improvement of menopausal symptoms
Measured: After 6 months or at discontinuation of Angeliq (At earlier point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startJun 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal PeriodStudies 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
- 4,078 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
- NCT01064453
- Sponsor's protocol ID
- 14841
- Other IDs
- AQ0710KR
- Acronym
- Angeliq rPMS
- Status last verified
- Nov 2013
- First submitted
- 5 Feb 2010
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angeliq Regulatory Post Marketing Surveillance
- ClinicalTrials.gov ID
- NCT01064453
- Acronym / sponsor ID
- Angeliq rPMS / 14841
- Keywords
- Menopause, Menopausal symptoms, Prevention of osteoporosis in menopausal women, Estrogen deficiency symptoms, Hormone replacement therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,078 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Feb 2010 (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.
Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-interventional , prospective, multi-center study.Target number of patients is 4500.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: E2/DRSP (Angeliq, BAY86-4891) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Korean women who take Angeliq for postmenopausal symptoms or/and prevention of osteoporosis
Key inclusion criteria (2 listed)
- Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause
- Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis
Key exclusion criteria (10 listed)
- Undiagnosed genital bleeding
- Known, past or suspected cancer of the breast
- Known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer)
- Untreated endometrial hyperplasia
- Previous idiopathic or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism)
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/DRSP (Angeliq, BAY86-4891)Take one tablet daily, continuously | Drug | Group 1 |
Primary outcome
Adverse event collection
Time frame: At each visit of patient during observational period (6 months)
1 secondary outcome
Improvement of menopausal symptoms
Time frame: After 6 months or at discontinuation of Angeliq (At earlier point)
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 19 Nov 2013.
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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 Postmenopausal Period and Osteoporosis, Postmenopausal, run by Bayer at 1 site in South Korea.
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 10 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 19 Nov 2013. 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 South Korea. 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?
Adverse event collection (time frame: At each visit of patient during observational period (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 19 Nov 2013.