Osteoporosis, PostmenopausalJULINA-CLIMANCT01386281
Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
An observational study of Osteoporosis, Postmenopausal, run by Bayer at 1 site in Japan.
Trial summary
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- E2 transdermal (Julina, BAY86-5435)
- How many people
- 506 participants
- Where
- 1 siteJapan
- Study dates
- 20 Oct 2008to 15 Apr 2014
- 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 is patients who have received a prescription of Julina on the basis of the decision of the treating gynecologist. The study is expected to collect data of 100 patients in about 20 gynecological practices in Japan.
Who may be able to join
- Patients who received Julina for postmenopausal osteoporosis
Who cannot join
- Patients who are contraindicated based on the product label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- E2 transdermal (Julina, BAY86-5435)
- Keywords
- Julina, Postmenopausal osteoporosis
- 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 transdermal (Julina, BAY86-5435)Drug
Patients in daily life treatment receiving Julina for postmenopausal osteoporosis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Drug (incl. Placebo) Receives: Drug: E2 transdermal (Julina, BAY86-5435) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions and serious adverse events in subject who received Julina
Measured: After Julina administration, upto 1 year
Secondary outcomes (3)
Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julina
Measured: At baseline and after Julina administration, upto 1 year
Change from baseline in grad of hot flush and sweating at the end of Julina treatment
Measured: At baseline and at end of Julina treatment, upto 1 year
Change from baseline in with/without vaginal atrophy at the end of Julina treatment
Measured: At baseline and at end of Julina treatment, upto 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study start20 Oct 2008
- Primary completion15 Apr 2014
- Study completion15 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 506 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
- NCT01386281
- Sponsor's protocol ID
- 15073
- Acronym
- JULINA-CLIMA
- Status last verified
- Apr 2018
- First submitted
- 16 Jun 2011
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
- ClinicalTrials.gov ID
- NCT01386281
- Acronym / sponsor ID
- JULINA-CLIMA / 15073
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Julina, Postmenopausal osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2008 (actual)
- Primary completion
- 15 Apr 2014 (actual)
- Study completion
- 15 Apr 2014 (actual)
- First posted
- 1 Jul 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 a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: E2 transdermal (Julina, BAY86-5435)Drug (incl. Placebo) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population of this study is patients who have received a prescription of Julina on the basis of the decision of the treating gynecologist. The study is expected to collect data of 100 patients in about 20 gynecological practices in Japan.
Key inclusion criteria (1 listed)
- Patients who received Julina for postmenopausal osteoporosis
Key exclusion criteria (1 listed)
- Patients who are contraindicated based on the product label
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 transdermal (Julina, BAY86-5435)Patients in daily life treatment receiving Julina for postmenopausal osteoporosis | Drug | Group 1 |
Primary outcome
Incidence of adverse drug reactions and serious adverse events in subject who received Julina
Time frame: After Julina administration, upto 1 year
3 secondary outcomes
Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julina
Time frame: At baseline and after Julina administration, upto 1 year
Change from baseline in grad of hot flush and sweating at the end of Julina treatment
Time frame: At baseline and at end of Julina treatment, upto 1 year
Change from baseline in with/without vaginal atrophy at the end of Julina treatment
Time frame: At baseline and at end of Julina treatment, upto 1 year
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 Apr 2018.
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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 Osteoporosis, Postmenopausal, run by Bayer at 1 site in Japan.
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 17 Apr 2018. 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 Japan. 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?
Incidence of adverse drug reactions and serious adverse events in subject who received Julina (time frame: After Julina administration, upto 1 year). 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 Apr 2018.