Study Results
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Basic Information
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COMPLETED
27840 participants
OBSERVATIONAL
2010-12-07
2019-01-26
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dienogest (DNG)
Women using DNG) for the treatment of endometriosis
No interventions assigned to this group
Other approved endometriosis drugs (OAED)
Women using hormonal medications approved for endometriosis treatment in all particiapting countries other than DNG.
No interventions assigned to this group
Non-approved endometriosis drugs (NAED)
Women using hormonal medications not approved for endometriosis treatment in all particiapting countries.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Women who are willing to participate in this long-term follow-up study
Exclusion Criteria
* Women with a language barrier
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Center for Epidemiology and Health Research, Germany
OTHER
Responsible Party
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Klaas Heinemann, MD, PhD
Principal Investigator
Principal Investigators
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Klaas Heinemann, PhD, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Center for Epidemiology and Health Research
Locations
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Center for Epidemiology and Health Research
Berlin, , Germany
Countries
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References
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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.
Becker 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.
Heinemann 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ZEG2010_03
Identifier Type: -
Identifier Source: org_study_id
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