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

Sponsor
Bayer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04495855
Collaborator
(none)
1,000
1
36
27.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dienogest (Visanne,BAY86_5258)

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice
Actual Study Start Date :
Oct 28, 2020
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Visanne treatment

Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne

Drug: Dienogest (Visanne,BAY86_5258)
2 mg (once a day), oral, tablet.

Outcome Measures

Primary Outcome Measures

  1. The absolute number of AEs reported with Visanne treatment [From baseline up to 6 months]

    AE: Adverse Event

  2. The absolute number of ADRs reported with Visanne treatment [From baseline up to 6 months]

    ADR: Adverse drug reaction

  3. 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.

  4. 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

  1. 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".

  2. 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).

  3. Patient and physician's satisfaction score on VisanneĀ® 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)

  4. 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

  5. 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

  6. 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

  7. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Many locations Multiple Locations China

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT04495855
Other Study ID Numbers:
  • 21088
First Posted:
Aug 3, 2020
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022