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NCT01788722 Clinical Trial

Regulatory Post Marketing Surveillance Study in Korea

Endometriosis Clinical Trial

Official title:
Visanne® (Dienogest 2mg) Regulatory Post Marketing Surveillance Study in Korea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01788722
Other study ID # 16625
Secondary ID VS1310KR
Status Completed
Phase
First received
Last updated
Start date July 19, 2013
Est. completion date August 11, 2017

Study information
Verified date July 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.

Recruitment information / eligibility
Status Completed
Enrollment 3223
Est. completion date August 11, 2017
Est. primary completion date August 11, 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Signed and dated informed consent

- Women diagnosed by a physician as having endometriosis

- Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period

Exclusion Criteria:

- All contraindications according to the local marketing authorization have to be considered.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dienogest (Visanne, BAY86-5258)
Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability up to 1 year
Secondary Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population 6 months and 1 year
Secondary Evaluation of VAS score changes for sub analysis( In case of VAS score= 30mm in initial visit). 6 months and 1 year
See also
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Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
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