check_circleStudy Completed

Endometriosis

Bayer Identifier:

21088

ClinicalTrials.gov Identifier:

NCT04495855

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to learn more about using dienogest to treat endometriosis in Chinese participants

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - 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

Trial summary

Enrollment Goal
968
Trial Dates
October 2020 - December 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, China

Primary Outcome

  • The absolute number of AEs reported with Visanne treatment
    AE: Adverse Event
    date_rangeTime Frame:
    From baseline up to 6 months
  • The absolute number of ADRs reported with Visanne treatment
    ADR: Adverse drug reaction
    date_rangeTime Frame:
    From baseline up to 6 months
  • 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.
    date_rangeTime Frame:
    From baseline up to 6 months
  • 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.
    date_rangeTime Frame:
    From baseline up to 6 months

Secondary Outcome

  • 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”.
    date_rangeTime Frame:
    From baseline up to 1,3,6 months
  • 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).
    date_rangeTime Frame:
    At baseline and 6 months.
  • 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)
    date_rangeTime Frame:
    At 3 and 6 months
  • 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
    date_rangeTime Frame:
    At 3 and 6 months
  • 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
    date_rangeTime Frame:
    At 3 and 6 months
  • 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
    date_rangeTime Frame:
    From baseline up to 6 months
  • The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne
    date_rangeTime Frame:
    At baseline, 1, 3, and 6 months

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
N/A

Additional Information

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