Trial Condition(s):
Endometriosis
Visanne Post-approval Observational Study (VIPOS) (VIPOS)
Bayer Identifier:
15214
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.
Inclusion Criteria
- 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
Exclusion Criteria
- Women who are not cooperative/available for follow-up - Women with a language barrier
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Poland | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Hungary | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Switzerland | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Ukraine | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
2
Primary Outcome
- AnemiaMedical intervention for anemia induced by cyclical bleeding disturbances (anemia)Timeframe: Within 6 years
- DepressionFirst time occurrence of clinically relevant depression, or worsening of existing depressionTimeframe: 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 periodsTimeframe: Within 6 years
Secondary Outcome
- Baseline characteristicsTimeframe: Within 6 years
- Drug utilization pattern, i.e. reason for treatment switching/discontinuationTimeframe: Within 6 years
- Short and long-term risks of endometriosis treatment in adolescent womenTimeframe: Within 6 years
Additional Information
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