A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants (VISANNE OS)

VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice

Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that lines the uterus starts to grow outside of the uterus. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life and requires long-term treatment to control the symptoms.

For some women with endometriosis, symptoms can return after they stop treatment. Or, they may not be able to tolerate the current long-term treatment options.

In this study, researchers will find out more about the safety of long-term treatment with dienogest in a large number of Chinese participants. This study will enroll patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis. All of the participants will take dienogest based on their doctor's instructions. They will then visit their doctor's office 3 times over 6 months. During these visits, their doctors will ask them if they have any health problems and about their quality of life. Their doctors will also do tests to measure the pain caused by their endometriosis and any other symptoms.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Dienogest (Visanne,BAY86_5258)

• Study Type: Observational
• Enrollment (Actual): 968

Contacts and Locations

Study Locations

• China
  • Multiple Locations, China
    • Many Locations

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Chinese patients from post-menarche to menopause diagnosed with endometriosis, either surgically or clinically, and prescribed with Visanne by a physician according to China's health authority approved label.

Description

Inclusion Criteria:

• Signed informed consent.
• Post-menarcheal age through menopause.
• Have clinically or surgically diagnosed endometriosis according to routine clinical practice.
• Decision for the treatment with Visanne was made as per physician's routine treatment practice.

Exclusion Criteria:

• Patients participating in an investigational program with interventions outside of routine clinical practice.
• Any contraindication according to Visanne Chinese label

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
Visanne treatment; Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne	Drug: Dienogest (Visanne,BAY86_5258); 2 mg (once a day), oral, tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The absolute number of AEs reported with Visanne treatment	AE: Adverse Event	From baseline up to 6 months
The absolute number of ADRs reported with Visanne treatment	ADR: Adverse drug reaction	From baseline up to 6 months
The proportion of AEs reported with Visanne treatment	Proportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients.	From baseline up to 6 months
The proportion of ADRs reported with Visanne treatment	Proportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients.	From baseline up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment	NRS: 0-10 integers."absence of pain" corresponds to the value of "0" and unbearable pain corresponding to the value of "10".	From baseline up to 1,3,6 months
Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment	EHP-5 contains 11 questions (items): five items including pain, control and powerlessness, emotional well-being, lack of social support, self image from the core questionnaire and six items from the modular questionnaire that may not be applicable to every woman with endometriosis including work, intercourse, and worries about infertility, treatment, and relationship with children and medical professionals. Each item is rated on a four-point scale (never = 0, rarely = 1, sometimes = 2, often = 3, always = 4 and not relevant if not applicable).	At baseline and 6 months.
Patient and physician's satisfaction score on Visanne® treatment	Satisfaction will be assessed in 5 scales (very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied)	At 3 and 6 months
Changes in Clinical Global Impression (CGI) scale scores of overall symptom development	CGI scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse	At 3 and 6 months
Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development	PGI-C scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse	At 3 and 6 months
Reasons for discontinuation of using Visanne	Discontinuation reasons identification: AEs (Exclude expected menstruation and treatment ineffective); Dissatisfaction with bleeding profile; Absence of symptoms; Treatment ineffective; Physicians decision; Switching to another treatment (another medicine or surgery); Wish to conceive; Others	From baseline up to 6 months
The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne		At baseline, 1, 3, and 6 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; 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: 21088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No