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Visanne Post-approval Observational Study (VIPOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01266421
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany

Tracking Information
First Submitted Date December 23, 2010
First Posted Date December 24, 2010
Last Update Posted Date July 29, 2020
Actual Study Start Date December 7, 2010
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 23, 2010)
  • Anemia [ Time Frame: Within 6 years ]
    Medical intervention for anemia induced by cyclical bleeding disturbances (anemia)
  • Depression [ Time Frame: Within 6 years ]
    First time occurence of clinically relevant depression, or worsening of existing depression
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Visanne Post-approval Observational Study (VIPOS)
Official Title International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observational Study
Brief Summary The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women using medications for the treatment of endometriosis
Condition Endometriosis
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2020)
27840
Original Estimated Enrollment
 (submitted: December 23, 2010)
25000
Actual Study Completion Date January 26, 2019
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Women who are not cooperative/available for follow-up
  • Women with a language barrier
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01266421
Other Study ID Numbers ZEG2010_03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany
Study Sponsor Center for Epidemiology and Health Research, Germany
Collaborators Bayer
Investigators
Principal Investigator: Klaas Heinemann, PhD, MD, MBA Center for Epidemiology and Health Research
PRS Account Center for Epidemiology and Health Research, Germany
Verification Date July 2020