EndometriosisNCT01788722
Regulatory Post Marketing Surveillance Study in Korea
An observational study of Endometriosis, run by Bayer at 1 site in South Korea.
Trial summary
The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Dienogest (Visanne, BAY86-5258)
- How many people
- 3,223 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2013to 11 Aug 2017
- 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: Women desiring treatment for endometriosis using Visanne (dienogest 2mg)
Who may be able to join
- Signed and dated informed consent
- Women diagnosed by a physician as having endometriosis
- Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period
Who cannot join
- All contraindications according to the local marketing authorization have to be considered.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visanne® (Dienogest 2mg) Regulatory Post Marketing Surveillance Study in Korea
The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.
- Conditions
- Endometriosis
- Being tested
- Dienogest (Visanne, BAY86-5258)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest (Visanne, BAY86-5258)Drug
Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Dienogest (Visanne, BAY86-5258) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability
Measured: up to 1 year
Secondary outcomes (2)
Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population
Measured: 6 months and 1 year
Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study start19 Jul 2013
- Primary completion11 Aug 2017
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- 3,223 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
- NCT01788722
- Sponsor's protocol ID
- 16625
- Other IDs
- VS1310KR
- Status last verified
- Jul 2018
- First submitted
- 8 Feb 2013
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visanne® (Dienogest 2mg) Regulatory Post Marketing Surveillance Study in Korea
- ClinicalTrials.gov ID
- NCT01788722
- Acronym / sponsor ID
- 16625
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,223 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2013 (actual)
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 11 Feb 2013 (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 objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Dienogest (Visanne, BAY86-5258) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women desiring treatment for endometriosis using Visanne (dienogest 2mg)
Key inclusion criteria (3 listed)
- Signed and dated informed consent
- Women diagnosed by a physician as having endometriosis
- Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period
Key exclusion criteria (1 listed)
- All contraindications according to the local marketing authorization have to be considered.
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 |
|---|---|---|
| Dienogest (Visanne, BAY86-5258)Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label. | Drug | Group 1 |
Primary outcome
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability
Time frame: up to 1 year
2 secondary outcomes
Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population
Time frame: 6 months and 1 year
Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).
Time frame: 6 months and 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 2 Aug 2018.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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 Endometriosis, 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 3 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 2 Aug 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 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?
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability (time frame: up to 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 2 Aug 2018.