NCT02425462 (ENVISIOeN) is a clinical trial of Dienogest (Visanne, BAY86-5258) in Endometriosis, sponsored by Bayer.

Who is sponsoring NCT02425462?

NCT02425462 is sponsored by Bayer.

What drugs are being tested in NCT02425462?

Interventions in NCT02425462: Dienogest (Visanne, BAY86-5258).

What condition does NCT02425462 study?

NCT02425462 studies Endometriosis.

Is NCT02425462 still recruiting?

NCT02425462 is currently completed. Last updated 25 September 2019.

Last reviewed 2019-09-25 · How we verify

NCT02425462: ENVISIOeN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis

Completed Last updated 25 September 2019

What this trial tests

trial testing Dienogest (Visanne, BAY86-5258) in Endometriosis in 895 participants. Completed in 14 December 2018.

Timeline

28 April 2015

Primary endpoint
28 September 2018

14 December 2018

Quick facts

Lead sponsor	Bayer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	895
Start date	28 April 2015
Primary completion	28 September 2018
Estimated completion	14 December 2018
Sites	6 locations across Malaysia, Indonesia, South Korea, Philippines, Thailand, Singapore

Drugs / interventions tested

Dienogest (Visanne, BAY86-5258) — full drug profile →

Conditions studied

Endometriosis — all drugs for Endometriosis →

Sponsor

Bayer — full company profile →

Who can join

18 and older, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 870 patients with endometriosis for whom a decision has been made by the physician to treat with dienogest according to local health authority approved label. It is the aim of this observational cohort study to further characterize the effectiveness of dienogest in improving quality of life and long-term safety in routine clinical practice setting. Endometriosis is chronic and progressive disease and there is unmet need for long-term treatment. Visanne® with proven efficacy and safety, can be good option for long-term treatment, however, experience with Visanne® beyond 15 month is limited. And long-term up to 24 months data on effectiveness and safety of Visanne would support the long-term treatment strategy for Endometriosis management in the clinical practice.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Pattern-recognition receptors in endometriosis: A narrative review.
Guo B, Chen JH, Zhang JH, Fang Y, et al · · 2023 · cited 21× · PMID 37033937 · DOI 10.3389/fimmu.2023.1161606
Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice.
Techatraisak K, Hestiantoro A, Ruey S, Banal-Silao MJ, et al · · 2019 · cited 15× · PMID 31096979 · DOI 10.1186/s12905-019-0758-6
Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN.
Techatraisak K, Hestiantoro A, Soon R, Banal-Silao MJ, et al · · 2022 · cited 14× · PMID 35112299 · DOI 10.1007/s43032-021-00787-w

Verify or expand the search:

Other trials of Dienogest (Visanne, BAY86-5258)

Trials testing the same drug.

NCT01788722 — Regulatory Post Marketing Surveillance Study in Korea · completed

Other recruiting trials for Endometriosis

Currently open trials in the same condition.

NCT06559852 — The Impact of Yoga on Endometriosis-Related Pain · NA · recruiting
NCT07393295 — Efficacy and Tolerability of TENS in Endometriosis-related Pain · NA · recruiting
NCT07134023 — Educational Program for the Multidisciplinary Support of Patients With Endometriosis · NA · recruiting
NCT07240883 — ENDO1000 - A UK-wide Endometriosis Research Project · recruiting
NCT06974773 — Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups · NA · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02425462 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 25 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02425462.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing