Visanne Post-approval Observational Study (VIPOS)

Endometriosis Clinical Trial

Official title:

International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266421
• Other study ID #: ZEG2010_03
• Status: Completed
• Start date: December 7, 2010
• Est. completion date: January 26, 2019

Study information

• Verified date: July 2020
• Source: Center for Epidemiology and Health Research, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27840
• Est. completion date: January 26, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Germany	Center for Epidemiology and Health Research	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Center for Epidemiology and Health Research, Germany	Bayer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	Medical intervention for anemia induced by cyclical bleeding disturbances (anemia)	Within 6 years
Primary	Depression	First time occurence of clinically relevant depression, or worsening of existing depression	Within 6 years