EndometriosisNCT01266421
Visanne Post-approval Observational Study (VIPOS)
An observational study of Endometriosis, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial summary
The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis
- How many people
- 27,840 participants
- Where
- 1 siteGermany
- Study dates
- 7 Dec 2010to 26 Jan 2019
- 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 using medications for the treatment of endometriosis
Who may be able to join
- Women using a newly prescribed regimen for endometriosis (first-time users or switchers or re-starters)
- Women who are willing to participate in this long-term follow-up study
Who cannot join
- Women who are not cooperative/available for follow-up
- Women with a language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observational Study
The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.
Read the detailed description
Endometriosis is a common, chronic, gynecological disease characterized by pain and impaired fertility. It causes chronic inflammation, ovarian cyst formation, fibrosis and adhesions. Symptoms seem to respond to decreased circulating estrogen. The mainstay of medical treatment is hormonal induced anovulation and a reduction in endogenous estrogen production.
Medications for endometriosis such as Danazol and GnRH agonists have clinically relevant side-effects limiting treatment duration with these medications to 6-12 months.
Dienogest (DNG) is a 19-nortestosterone derivative progestogen. DNG 2mg/day is a reliable and effective treatment for dysmenorrhea, premenstrual pain, dyspareunia and diffuse pelvic pain associated with endometriosis.
Two important class effects of progestogens are the induction of bleeding disturbances and their influence on mood disturbance. It is not known what influence DNG will have on bleeding disturbances associated with endometriosis, particularly over a longer time frame.
In addition, women who suffer from endometriosis are at high risk of developing depressive symptoms. It is difficult to differentiate if depressive symptoms are causally associated with progestogen use or sequela of the disease process.
This study investigates the safety of DNG for endometriosis with regard to medical interventions for anemia and worsening of depressive symptoms associated with the disease. It is a prospective, controlled, non-interventional cohort study with two cohorts: users of DNG and users of other medications for the treatment of endometriosis. The study will be implemented in several European countries.
- Conditions
- Endometriosis
- Keywords
- DNG, Anemia, Depression
- Medical subject headings
- Endometriosis, Anemia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dienogest (DNG) | Women using DNG) for the treatment of endometriosis | |
| Other approved endometriosis drugs (OAED) | Women using hormonal medications approved for endometriosis treatment in all particiapting countries other than DNG. | |
| Non-approved endometriosis drugs (NAED) | Women using hormonal medications not approved for endometriosis treatment in all particiapting countries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
Medical intervention for anemia induced by cyclical bleeding disturbances (anemia)
Measured: Within 6 years
Depression
First time occurence of clinically relevant depression, or worsening of existing depression
Measured: Within 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study start7 Dec 2010
- Primary completion31 Oct 2018
- Study completion26 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- 27,840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany
- Investigators
- Klaas Heinemann, PhD, MD, MBA, Principal investigator, Center for Epidemiology and Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266421
- Sponsor's protocol ID
- ZEG2010_03
- Status last verified
- Jul 2020
- First submitted
- 23 Dec 2010
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moehner S, Becker K, Lange JA, von Stockum S, Heinemann K. Risk of depression and anemia in users of hormonal endometriosis treatments: Results from the VIPOS study. Eur J Obstet Gynecol Reprod Biol. 2020 Aug;251:212-217. doi: 10.1016/j.ejogrb.2020.05.049. Epub 2020 Jun 2.
PubMed 32559605Becker K, Heinemann K, Imthurn B, Marions L, Moehner S, Gerlinger C, Serrani M, Faustmann T. Real world data on symptomology and diagnostic approaches of 27,840 women living with endometriosis. Sci Rep. 2021 Oct 14;11(1):20404. doi: 10.1038/s41598-021-99681-3.
PubMed 34650132Heinemann K, Imthurn B, Marions L, Gerlinger C, Becker K, Moehner S, Faustmann T. Safety of Dienogest and Other Hormonal Treatments for Endometriosis in Real-World Clinical Practice (VIPOS): A Large Noninterventional Study. Adv Ther. 2020 May;37(5):2528-2537. doi: 10.1007/s12325-020-01331-z. Epub 2020 Apr 16.
PubMed 32301063
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observational Study
- ClinicalTrials.gov ID
- NCT01266421
- Acronym / sponsor ID
- ZEG2010_03
- Conditions
- Endometriosis
- Keywords
- DNG, Anemia, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,840 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 7 Dec 2010 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 26 Jan 2019 (actual)
- First posted
- 24 Dec 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.
The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.
Detailed description
Endometriosis is a common, chronic, gynecological disease characterized by pain and impaired fertility. It causes chronic inflammation, ovarian cyst formation, fibrosis and adhesions. Symptoms seem to respond to decreased circulating estrogen. The mainstay of medical treatment is hormonal induced anovulation and a reduction in endogenous estrogen production.
Medications for endometriosis such as Danazol and GnRH agonists have clinically relevant side-effects limiting treatment duration with these medications to 6-12 months.
Dienogest (DNG) is a 19-nortestosterone derivative progestogen. DNG 2mg/day is a reliable and effective treatment for dysmenorrhea, premenstrual pain, dyspareunia and diffuse pelvic pain associated with endometriosis.
Two important class effects of progestogens are the induction of bleeding disturbances and their influence on mood disturbance. It is not known what influence DNG will have on bleeding disturbances associated with endometriosis, particularly over a longer time frame.
In addition, women who suffer from endometriosis are at high risk of developing depressive symptoms. It is difficult to differentiate if depressive symptoms are causally associated with progestogen use or sequela of the disease process.
This study investigates the safety of DNG for endometriosis with regard to medical interventions for anemia and worsening of depressive symptoms associated with the disease. It is a prospective, controlled, non-interventional cohort study with two cohorts: users of DNG and users of other medications for the treatment of endometriosis. The study will be implemented in several European countries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dienogest (DNG) | – | –Women using DNG) for the treatment of endometriosis |
| Other approved endometriosis drugs (OAED) | – | –Women using hormonal medications approved for endometriosis treatment in all particiapting countries other than DNG. |
| Non-approved endometriosis drugs (NAED) | – | –Women using hormonal medications not approved for endometriosis treatment in all particiapting countries. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women using medications for the treatment of endometriosis
Key inclusion criteria (2 listed)
- Women using a newly prescribed regimen for endometriosis (first-time users or switchers or re-starters)
- Women who are willing to participate in this long-term follow-up study
Key exclusion criteria (2 listed)
- Women who are not cooperative/available for follow-up
- Women with a language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anemia
Time frame: Within 6 years
Medical intervention for anemia induced by cyclical bleeding disturbances (anemia)
Depression
Time frame: Within 6 years
First time occurence of clinically relevant depression, or worsening of existing depression
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 29 Jul 2020.
- Results publication: PubMed 32559605Moehner S, Becker K, Lange JA, von Stockum S, Heinemann K. Risk of depression and anemia in users of hormonal endometriosis treatments: Results from the VIPOS study. Eur J Obstet Gynecol Reprod Biol. 2020 Aug;251:212-217. doi: 10.1016/j.ejogrb.2020.05.049. Epub 2020 Jun 2.
- Derived from this study: PubMed 34650132Becker K, Heinemann K, Imthurn B, Marions L, Moehner S, Gerlinger C, Serrani M, Faustmann T. Real world data on symptomology and diagnostic approaches of 27,840 women living with endometriosis. Sci Rep. 2021 Oct 14;11(1):20404. doi: 10.1038/s41598-021-99681-3.
- Derived from this study: PubMed 32301063Heinemann K, Imthurn B, Marions L, Gerlinger C, Becker K, Moehner S, Faustmann T. Safety of Dienogest and Other Hormonal Treatments for Endometriosis in Real-World Clinical Practice (VIPOS): A Large Noninterventional Study. Adv Ther. 2020 May;37(5):2528-2537. doi: 10.1007/s12325-020-01331-z. Epub 2020 Apr 16.
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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.
Klaas Heinemann, PhD, MD, MBA principal investigator
Center for Epidemiology and Health Research
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 Center for Epidemiology and Health Research, Germany at 1 site in Germany.
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 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 29 Jul 2020. 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 Germany. 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?
Anemia (time frame: Within 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01266421, which also lists 3 linked publications.
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 29 Jul 2020.