A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants

Endometriosis Clinical Trial

— VISANNE OS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495855
• Other study ID #: 21088
• Status: Completed
• Start date: October 28, 2020
• Est. completion date: December 23, 2022

Study information

• Verified date: December 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 968
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Dienogest (Visanne,BAY86_5258)
2 mg (once a day), oral, tablet.

Locations

Country	Name	City	State
China	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absolute number of AEs reported with Visanne treatment	AE: Adverse Event	From baseline up to 6 months
Primary	The absolute number of ADRs reported with Visanne treatment	ADR: Adverse drug reaction	From baseline up to 6 months
Primary	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
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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