UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058218 |
|---|---|
| Receipt number | R000066556 |
| Scientific Title | Treatment issues in Japanese patients with uterine fibroids: a mixed methods study with interviews and questionnaires |
| Date of disclosure of the study information | 2025/06/19 |
| Last modified on | 2025/06/19 13:27:22 |
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Basic information
Public title
Treatment issues in Japanese patients with uterine fibroids: a mixed methods study with interviews and questionnaires
Acronym
Treatment issues in Japanese patients with uterine fibroids: a mixed methods study with interviews and questionnaires
Scientific Title
Treatment issues in Japanese patients with uterine fibroids: a mixed methods study with interviews and questionnaires
Scientific Title:Acronym
Treatment issues in Japanese patients with uterine fibroids: a mixed methods study with interviews and questionnaires
Region
| Japan |
Condition
Condition
uterine fibroids
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the current experiences and issues before medical examination and during drug treatment for uterine fibroids
Basic objectives2
Others
Basic objectives -Others
-Interview survey: To identify the conflicts before treatment, satisfaction with treatment, and unmet issues.
-Questionnaire survey: To confirm the generalizability of the issues regarding medical examination and treatment obtained from the interview survey.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Interview survey
-History of the detection of uterine fibroids
-History of diagnosis and treatment decision
-History after the start of treatment
-Experience of treatment
etc.
Questionnaire survey
-Before treatment:
-What triggered the patient to notice or suspect that the patient had uterine fibroids
-The time of the patient was aware that the patient had uterine fibroids
-Impact on work and life
-Behavior and psychology before medical examination
etc.
-After the start of treatment
-Triggers for medical examination for uterine fibroids
-The period from recognition of symptoms and findings of uterine fibroids to medical examination
-Anxiety about receiving a medical examination for uterine fibroids
-The purpose of treatment and factors in determining treatment plan
etc.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1)Interview survey
1. Patients who will provide electronic consent to participate in the study
2. Patients aged 40 to 49 years
3. Patients who are Japanese and receiving medical treatment in Japan
4. Patients who have not undergone surgical treatment for uterine fibroids
5. Patients with symptoms (heavy menstrual bleeding, anemia, lower abdominal pain, etc.) due to uterine fibroids
6. Patients who are on drug treatment for uterine fibroids using drugs prescribed by a medical institution and who have been on the treatment for less than 6 months.
7. Patients who have experienced any difficulty in receiving medical examination or treatment.
2)Questionnaire survey
1. Patients who will provide electronic consent to participate in the study
2. Patients aged 40 to 49 years
3. Patients who are Japanese and receiving medical treatment in Japan
4. Patients who have not undergone surgical treatment for uterine fibroids
5. Patients with symptoms (heavy menstrual bleeding, anemia, lower abdominal pain, etc.) due to uterine fibroids
6. Patients who are on drug treatment for uterine fibroids using drugs prescribed by a medical institution and who have been on the treatment for less than 6 months.
Key exclusion criteria
1)Interview survey
1. Patients who cannot answer at all about the type of drug treatment they are receiving
2. Patients with psychiatric disorders
3. Patients who are participating in other clinical studies other than this study, including clinical trials
4. Patients with malignant tumors
2)Questionnaire survey
1. Patients with psychiatric disorders
2. Patients who are participating in other clinical studies other than this study, including clinical trials
3. Patients with malignant tumors
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Nyui |
Organization
KISSEI PHARMACEUTICAL CO., LTD.
Division name
Medical Department
Zip code
103-0022
Address
Kissei Nihonbashi Building, 1-8-9 Nihonbashi Muromachi, Chuo-ku, Tokyo, Japan
TEL
03-3279-2306
ikuyaku@pharm.kissei.co.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Tobe |
Organization
Mebix, Inc.
Division name
Medical Science & Writing Group
Zip code
107-0052
Address
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-4362-4500
Homepage URL
uterine_fibroid_mmr@mebix.co.jp
Sponsor or person
Institute
KISSEI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KISSEI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Address
1-9-2 Nihonbashikayabacho, Chuo-ku, Tokyo
Tel
03-6777-1490
c-irb_ug@neues.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A mixed methods study with interviews and questionnaires
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066556
