Clinical trial NCT01266421: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: DNG
Anemia
Depression
Lead sponsor: Center for Epidemiology and Health Research, Germany
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2010-12-24
Enrollment: 27840
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women using medications for the treatment of endometriosis

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.

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

Primary outcomes:
measure: Anemia
timeFrame: Within 6 years
measure: Depression
timeFrame: Within 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Epidemiology and Health Research
Study officials:
affiliation: Center for Epidemiology and Health Research
name: Klaas Heinemann, PhD, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2020 Jun 2.
citation: Becker K, Heinemann K, Imthurn B, Marions L, Moehner S, Gerlinger C, Serrani M, Faustmann T. Real world data on symptomology and diagnostic approaches of 27,840 women living with endometriosis. Sci Rep. 2021 Oct 14;11(1):20404. doi: 10.1038/s41598-021-99681-3.
citation: Heinemann K, Imthurn B, Marions L, Gerlinger C, Becker K, Moehner S, Faustmann T. Safety of Dienogest and Other Hormonal Treatments for Endometriosis in Real-World Clinical Practice (VIPOS): A Large Noninterventional Study. Adv Ther. 2020 May;37(5):2528-2537. doi: 10.1007/s12325-020-01331-z. Epub 2020 Apr 16.