Visanne Post-approval Observational Study (VIPOS)
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| ClinicalTrials.gov Identifier: NCT01266421 |
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Recruitment Status :
Completed
First Posted : December 24, 2010
Last Update Posted : July 29, 2020
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| Condition or disease |
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| Endometriosis |
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 : | 27840 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observational Study |
| Actual Study Start Date : | December 7, 2010 |
| Actual Primary Completion Date : | October 31, 2018 |
| Actual Study Completion Date : | January 26, 2019 |
| Group/Cohort |
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Dienogest (DNG)
Women using DNG) for the treatment of endometriosis
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Other approved endometriosis drugs (OAED)
Women using hormonal medications approved for endometriosis treatment in all particiapting countries other than DNG.
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Non-approved endometriosis drugs (NAED)
Women using hormonal medications not approved for endometriosis treatment in all particiapting countries.
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- 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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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
| Germany | |
| Center for Epidemiology and Health Research | |
| Berlin, Germany, 10115 | |
| Principal Investigator: | Klaas Heinemann, PhD, MD, MBA | Center for Epidemiology and Health Research |
Documents provided by Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Klaas Heinemann, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany |
| ClinicalTrials.gov Identifier: | NCT01266421 |
| Other Study ID Numbers: |
ZEG2010_03 |
| First Posted: | December 24, 2010 Key Record Dates |
| Last Update Posted: | July 29, 2020 |
| Last Verified: | July 2020 |
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DNG Anemia Depression |
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Endometriosis |