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Completed

NCT Number: NCT04495855

A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Many locations

Multiple Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dienogest (Visanne,BAY86_5258)

Drug

2 mg (once a day), oral, tablet.

Primary outcomes

  1. The absolute number of AEs reported with Visanne treatment

    Time frame: From baseline up to 6 months

    AE: Adverse Event

  2. The absolute number of ADRs reported with Visanne treatment

    Time frame: From baseline up to 6 months

    ADR: Adverse drug reaction

  3. The proportion of AEs reported with Visanne treatment

    Time frame: 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.

  4. The proportion of ADRs reported with Visanne treatment

    Time frame: 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 outcomes

  1. Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment

    Time frame: 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".

  2. Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment

    Time frame: 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).

  3. Patient and physician's satisfaction score on Visanne® treatment

    Time frame: At 3 and 6 months

    Satisfaction will be assessed in 5 scales (very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied)

  4. Changes in Clinical Global Impression (CGI) scale scores of overall symptom development

    Time frame: At 3 and 6 months

    CGI scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

  5. Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development

    Time frame: At 3 and 6 months

    PGI-C scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

  6. Reasons for discontinuation of using Visanne

    Time frame: 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

  7. The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne

    Time frame: At baseline, 1, 3, and 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice

Acronym: VISANNE OS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2020
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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