A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants
- Registration Number
- NCT04495855
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 968
- 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.
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Any contraindication according to Visanne Chinese label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Visanne treatment Dienogest (Visanne,BAY86_5258) Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne
- Primary Outcome Measures
Name Time Method The absolute number of AEs reported with Visanne treatment From baseline up to 6 months AE: Adverse Event
The proportion of AEs reported with Visanne treatment From baseline up to 6 months Proportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients.
The absolute number of ADRs reported with Visanne treatment From baseline up to 6 months ADR: Adverse drug reaction
The proportion of ADRs reported with Visanne treatment From baseline up to 6 months Proportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients.
- Secondary Outcome Measures
Name Time Method Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment From baseline up to 1,3,6 months NRS: 0-10 integers."absence of pain" corresponds to the value of "0" and unbearable pain corresponding to the value of "10".
Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment At baseline and 6 months. 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).
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 Changes in Clinical Global Impression (CGI) scale scores of overall symptom development At 3 and 6 months CGI scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development At 3 and 6 months PGI-C scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse
Reasons for discontinuation of using Visanne From baseline up to 6 months 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
* OthersPatient and physician's satisfaction score on Visanne® treatment At 3 and 6 months Satisfaction will be assessed in 5 scales (very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied)
Trial Locations
- Locations (1)
Many locations
🇨🇳Multiple Locations, China