NCT01788722

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

July 19, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2017

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

4.1 years

First QC Date

February 8, 2013

Last Update Submit

July 31, 2018

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

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

    up to 1 year

Secondary Outcomes (2)

  • 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

Study Arms (1)

Group 1

Drug: Dienogest (Visanne, BAY86-5258)

Interventions

Dienogest (Visanne, BAY86-5258)DRUG

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

Group 1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, South Korea

Location

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 11, 2013

Study Start

July 19, 2013

Primary Completion

August 11, 2017

Study Completion

August 11, 2017

Last Updated

August 2, 2018

Record last verified: 2018-07

Locations

KR(1)