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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Anemia | Medical intervention for anemia induced by cyclical bleeding disturbances (anemia) | Within 6 years |
| Depression | First time occurence of clinically relevant depression, or worsening of existing depression | Within 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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Women using medications for the treatment of endometriosis
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| Name | Affiliation | Role |
|---|---|---|
| Klaas Heinemann, PhD, MD, MBA | Center for Epidemiology and Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Epidemiology and Health Research | Berlin | 10115 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32559605 | Result | 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. | |
| 34650132 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2011 | Jul 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2019 | Jul 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D000740 | Anemia |
| D003863 | Depression |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 32301063 | Derived | 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. |
| D000091662 | Genital Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |