EndometriosisVISANNE OSNCT04495855
A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants
An observational study of Endometriosis, run by Bayer at 1 site in China.
Trial summary
Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that lines the uterus starts to grow outside of the uterus. This can cause pain during their periods or during sex, and constant pain in the pelvis. 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)
- Type of treatment
- Pill or oral medicine
- How many people
- 968 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2020to 23 Dec 2022
- 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: Chinese patients from post-menarche to menopause diagnosed with endometriosis, either surgically or clinically, and prescribed with Visanne by a physician according to China's health authority approved label.
Who may be able to join
- Signed informed consent.
- Post-menarcheal age through menopause.
- Have clinically or surgically diagnosed endometriosis according to routine clinical practice.
- Decision for the treatment with Visanne was made as per physician's routine treatment practice.
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Any contraindication according to Visanne Chinese label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice
Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that lines the uterus starts to grow outside of the uterus. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life and requires long-term treatment to control the symptoms.
For some women with endometriosis, symptoms can return after they stop treatment. Or, they may not be able to tolerate the current long-term treatment options.
In this study, researchers will find out more about the safety of long-term treatment with dienogest in a large number of Chinese participants. This study will enroll patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis. All of the participants will take dienogest based on their doctor's instructions. They will then visit their doctor's office 3 times over 6 months. During these visits, their doctors will ask them if they have any health problems and about their quality of life. Their doctors will also do tests to measure the pain caused by their endometriosis and any other symptoms.
- 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
2 mg (once a day), oral, tablet.
| Study group | Role | What they receive |
|---|---|---|
| Visanne treatment | Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne Receives: Drug: Dienogest (Visanne,BAY86_5258) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute number of AEs reported with Visanne treatment
AE: Adverse Event
Measured: From baseline up to 6 months
The absolute number of ADRs reported with Visanne treatment
ADR: Adverse drug reaction
Measured: From baseline up to 6 months
The proportion of AEs reported with Visanne treatment
Proportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients.
Measured: From baseline up to 6 months
The proportion of ADRs reported with Visanne treatment
Proportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients.
Measured: From baseline up to 6 months
Secondary outcomes (7)
Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment
NRS: 0-10 integers."absence of pain" corresponds to the value of "0" and unbearable pain corresponding to the value of "10".
Measured: From baseline up to 1,3,6 months
Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment
EHP-5 contains 11 questions (items): five items including pain, control and powerlessness, emotional well-being, lack of social support, self image from the core questionnaire and six items from the modular questionnaire that may not be applicable to every woman with endometriosis including work, intercourse, and worries about infertility, treatment, and relationship with children and medical professionals. Each item is rated on a four-point scale (never = 0, rarely = 1, sometimes = 2, often = 3, always = 4 and not relevant if not applicable).
Measured: At baseline and 6 months.
Patient and physician's satisfaction score on Visanne® treatment
Satisfaction will be assessed in 5 scales (very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied)
Measured: At 3 and 6 months
Changes in Clinical Global Impression (CGI) scale scores of overall symptom development
CGI scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Measured: At 3 and 6 months
Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development
PGI-C scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Measured: At 3 and 6 months
Reasons for discontinuation of using Visanne
Discontinuation reasons identification:
- AEs (Exclude expected menstruation and treatment ineffective)
- Dissatisfaction with bleeding profile
- Absence of symptoms
- Treatment ineffective
- Physicians decision
- Switching to another treatment (another medicine or surgery)
- Wish to conceive
- Others
Measured: From baseline up to 6 months
The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne
Measured: At baseline, 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start28 Oct 2020
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
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
- 968 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495855
- Sponsor's protocol ID
- 21088
- Acronym
- VISANNE OS
- Status last verified
- Dec 2023
- First submitted
- 14 Jul 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice
- ClinicalTrials.gov ID
- NCT04495855
- Acronym / sponsor ID
- VISANNE OS / 21088
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 3 Aug 2020 (actual)
- 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.
Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that lines the uterus starts to grow outside of the uterus. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life and requires long-term treatment to control the symptoms.
For some women with endometriosis, symptoms can return after they stop treatment. Or, they may not be able to tolerate the current long-term treatment options.
In this study, researchers will find out more about the safety of long-term treatment with dienogest in a large number of Chinese participants. This study will enroll patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis. All of the participants will take dienogest based on their doctor's instructions. They will then visit their doctor's office 3 times over 6 months. During these visits, their doctors will ask them if they have any health problems and about their quality of life. Their doctors will also do tests to measure the pain caused by their endometriosis and any other symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visanne treatment | – | Drug: Dienogest (Visanne,BAY86_5258)Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese patients from post-menarche to menopause diagnosed with endometriosis, either surgically or clinically, and prescribed with Visanne by a physician according to China's health authority approved label.
Key inclusion criteria (4 listed)
- Signed informed consent.
- Post-menarcheal age through menopause.
- Have clinically or surgically diagnosed endometriosis according to routine clinical practice.
- Decision for the treatment with Visanne was made as per physician's routine treatment practice.
Key exclusion criteria (2 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Any contraindication according to Visanne Chinese 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 |
|---|---|---|
| Dienogest (Visanne,BAY86_5258)2 mg (once a day), oral, tablet. | Drug | Visanne treatment |
Primary outcome
The absolute number of AEs reported with Visanne treatment
Time frame: From baseline up to 6 months
AE: Adverse Event
The absolute number of ADRs reported with Visanne treatment
Time frame: From baseline up to 6 months
ADR: Adverse drug reaction
The proportion of AEs reported with Visanne treatment
Time frame: From baseline up to 6 months
Proportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients.
The proportion of ADRs reported with Visanne treatment
Time frame: From baseline up to 6 months
Proportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients.
7 secondary outcomes
Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment
Time frame: From baseline up to 1,3,6 months
Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment
Time frame: At baseline and 6 months.
Patient and physician's satisfaction score on Visanne® treatment
Time frame: At 3 and 6 months
Changes in Clinical Global Impression (CGI) scale scores of overall symptom development
Time frame: At 3 and 6 months
Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development
Time frame: At 3 and 6 months
Reasons for discontinuation of using Visanne
Time frame: From baseline up to 6 months
The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne
Time frame: At baseline, 1, 3, and 6 months
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 12 Dec 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 China.
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 4 inclusion and 2 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 12 Dec 2023. 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 China. 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?
The absolute number of AEs reported with Visanne treatment (time frame: From baseline up to 6 months). The study lists 4 primary outcomes in all. 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 12 Dec 2023.