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OpenTrials
Completed

NCT Number: NCT01788722

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Multiple Locations, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dienogest (Visanne, BAY86-5258)

Drug

Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.

Primary outcomes

  1. Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability

    Time frame: up to 1 year

Secondary outcomes

  1. Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population

    Time frame: 6 months and 1 year

  2. Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).

    Time frame: 6 months and 1 year

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2013
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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