International Active Surveillance Study of Women Taking Dienogest for Endometriosis: Visanne Post-approval Observational Study (VIPOS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DIENOGEST
• Medical condition to be studied:
  Endometriosis

  Depression

  Blood loss anaemia

Population studied

• Short description of the study population:
  The study participants were women who; 1. Were users of a newly prescribed regimen for endometriosis (starters, restarters or switchers); 2. Were willing to participate in this long-term follow-up study
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  25000

Study design details

• Main study objective:
  To assess the safety aspects of Dienogest 2mg/dya (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis in a study population that is prepresentative for the actual users of the individual preparations. This includes an estimate of the absolute risk of rare serious adverse events.
• Outcomes:
  -Medical intervention for anemia induced by cyclical bleeding disturbances (anaemia)-First time occurence of clinically relevant depression, or worsening of existing depression-Discontinuation patterns of DNG and other endometriosis treatments due to treatment failure (eg reoccurence of pain, adverse drug reaction), -Characterise baseline risk of users of the individual endometriosis treatments-Analyse the drug utilisation patterns of endometriosis treatments in a study population that is representative for typical users -Investigate risks of short and long-term use of DNG and of established endometriosis treatments in young women below the age of 18 years
• Data analysis plan:
  Inferential statistics for anemia and depression were based on Cox proportional hazards models. Crude hazard ratios (HR) between cohorts were calculated for these outcomes of interest. If the numbers allowed for stable estimates, adjustment for potential confounding was performed by including predefined prognostic factors as covariates in the Cox proportional hazard models. To account for heterogeneity country was included as stratum. The risk of treatment failure was obtained with the generalized estimating equations (GEE) . Crude and adjusted odds ratios were calculated.For each of the outcomes of interest, a limited number of prognostic factors were chosen by the members of the Safety Monitoring and Advisory Council based on their expertise.All statistical analyses were performed using SAS 9.4.

Documents

Study results

INAS-VIPOS_FinalStudyReport_PublicVersion