Clinical trial NCT04495855: A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants
Official title: VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 968
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The absolute number of AEs reported with Visanne treatment
timeFrame: From baseline up to 6 months
measure: The absolute number of ADRs reported with Visanne treatment
timeFrame: From baseline up to 6 months
measure: The proportion of AEs reported with Visanne treatment
timeFrame: From baseline up to 6 months
measure: The proportion of ADRs reported with Visanne treatment
timeFrame: From baseline up to 6 months
Secondary outcomes:
measure: Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment
timeFrame: From baseline up to 1,3,6 months
measure: Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment
timeFrame: At baseline and 6 months.
measure: Patient and physician's satisfaction score on Visanne® treatment
timeFrame: At 3 and 6 months
measure: Changes in Clinical Global Impression (CGI) scale scores of overall symptom development
timeFrame: At 3 and 6 months
measure: Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development
timeFrame: At 3 and 6 months
measure: Reasons for discontinuation of using Visanne
timeFrame: From baseline up to 6 months
measure: The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne
timeFrame: At baseline, 1, 3, and 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: China
facility: Many locations
Study officials:
References: