Regulatory Post Marketing Surveillance Study in Korea

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Dienogest (Visanne, BAY86-5258)

• Study Type: Observational
• Enrollment (Actual): 3223

Contacts and Locations

Study Locations

• Korea, Republic of
  • Multiple Locations, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women desiring treatment for endometriosis using Visanne (dienogest 2mg)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Dienogest (Visanne, BAY86-5258); Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability	up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population	6 months and 1 year
Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).	6 months and 1 year

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2013
• Primary Completion (Actual): August 11, 2017
• Study Completion (Actual): August 11, 2017

Study Registration Dates

• First Submitted: February 8, 2013
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Dienogest
• Other Study ID Numbers: 16625; VS1310KR (Other Identifier: company internal)