Trial Condition(s):
Endometriosis
A study to learn more about using dienogest to treat endometriosis in Chinese participants (VISANNE OS)
Bayer Identifier:
21088
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
VISANNE OS/Treatment of endometriosis with Dienogest in the real world clinical practice
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- The absolute number of AEs reported with Visanne treatmentAE: Adverse EventTimeframe: From baseline up to 6 months
- The absolute number of ADRs reported with Visanne treatmentADR: Adverse drug reactionTimeframe: From baseline up to 6 months
- The proportion of AEs reported with Visanne treatmentProportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients.Timeframe: From baseline up to 6 months
- The proportion of ADRs reported with Visanne treatmentProportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients.Timeframe: From baseline up to 6 months
Secondary Outcome
- Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatmentNRS: 0-10 integers.“absence of pain” corresponds to the value of “0” and unbearable pain corresponding to the value of “10”.Timeframe: From baseline up to 1,3,6 months
- Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatmentEHP-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).Timeframe: At baseline and 6 months.
- Patient and physician's satisfaction score on Visanne® treatmentSatisfaction will be assessed in 5 scales (very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied)Timeframe: At 3 and 6 months
- Changes in Clinical Global Impression (CGI) scale scores of overall symptom developmentCGI scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worseTimeframe: At 3 and 6 months
- Changes in Patient Global Impression (PGI-C) scale scores of overall symptom developmentPGI-C scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worseTimeframe: At 3 and 6 months
- Reasons for discontinuation of using VisanneDiscontinuation 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 - OthersTimeframe: From baseline up to 6 months
- The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with VisanneTimeframe: At baseline, 1, 3, and 6 months
Additional Information
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