Visanne Post-approval Observational Study (VIPOS)
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|ClinicalTrials.gov Identifier: NCT01266421|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : August 10, 2018
|Condition or disease|
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|
|Actual Enrollment :||28400 participants|
|Official Title:||International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observational Study|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||March 2019|
Women using DNG for the treatment of endometriosis
Women using hormonal medications other than DNG for the treatment of endometriosis
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266421
|Center for Epidemiology and Health Research|
|Berlin, Germany, 10115|
|Principal Investigator:||Klaas Heinemann, PhD, MD, MBA||Center for Epidemiology and Health Research|