Endometriosis
Conditions
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.
Interventions
DRUGDienogest (Visanne,BAY86_5258)
2 mg (once a day), oral, tablet.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The absolute number of AEs reported with Visanne treatment | From baseline up to 6 months | AE: Adverse Event |
| The absolute number of ADRs reported with Visanne treatment | From baseline up to 6 months | ADR: Adverse drug reaction |
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 | — |
| 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 * Others |
| 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). |
| Patient 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) |
| 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 |
Countries
China
Outcome results
None listed