check_circleStudy Completed

Endometriosis

Bayer Identifier:

15214

ClinicalTrials.gov Identifier:

NCT01266421

EudraCT Number:

Not Available

EU CT Number:

Not Available
Visanne Post-approval Observational Study (VIPOS)

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - Women using a newly prescribed regimen for endometriosis (first-time users or switchers)
    - Women who are willing to participate in this long-term follow-up study
  • - Women who are not cooperative/available for follow-up
    - Women with a language barrier

Trial summary

Enrollment Goal
27840
Trial Dates
December 2010 - January 2019
Phase
N/A
Could I Receive a placebo
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Germany
Completed
Many locations, Poland
Completed
Many locations, Hungary
Completed
Many locations, Switzerland
Completed
Many locations, Russia
Completed
Many locations, Ukraine

Primary Outcome

  • Anemia
    Medical intervention for anemia induced by cyclical bleeding disturbances (anemia)
    date_rangeTime Frame:
    Within 6 years
  • Depression
    First time occurrence of clinically relevant depression, or worsening of existing depression
    date_rangeTime Frame:
    Within 6 years
  • Treatment failure
    ‘Treatment failure’ is defined as cessation of treatment caused by lack of efficacy, loss of efficacy or an adverse drug reaction and does not include women who stop treatment after pre-defined treatment periods
    date_rangeTime Frame:
    Within 6 years

Secondary Outcome

  • Baseline characteristics
    date_rangeTime Frame:
    Within 6 years
  • Drug utilization pattern, i.e. reason for treatment switching/discontinuation
    date_rangeTime Frame:
    Within 6 years
  • Short and long-term risks of endometriosis treatment in adolescent women
    date_rangeTime Frame:
    Within 6 years

Trial design

International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observational Study
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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