Visanne Post-approval Observational Study (VIPOS)

NCT01266421 | Completed DMC

• 1 other identifier: ZEG2010_03
• Study Type: observational
• Target: 27,840
• Locations: 1 country
• Sites: 1

Brief Summary

The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.

Conditions

Endometriosis

Keywords

DNG; Anemia; Depression

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women using medications for the treatment of endometriosis

You may qualify if:

• 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

You may not qualify if:

• Women who are not cooperative/available for follow-up
• Women with a language barrier

Sponsors & Collaborators

• Center for Epidemiology and Health Research, Germany: lead
• Bayer: collaborator

Study Sites (1)

Center for Epidemiology and Health Research

Berlin, 10115, Germany

Location

Related Publications (3)

• 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.

  PMID: 32559605 RESULT

• 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.

  PMID: 34650132 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.

  PMID: 32301063 DERIVED

MeSH Terms

Conditions

Endometriosis; Anemia; Depression

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Klaas Heinemann, PhD, MD, MBA

  Center for Epidemiology and Health Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: December 7, 2010
• Primary Completion: October 31, 2018
• Study Completion: January 26, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

DE (1)