UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031074 |
|---|---|
| Receipt number | R000035490 |
| Scientific Title | The effects of inhibition and pain-improving in human endometriosis and in an endometriosis mouse model. |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2023/02/04 19:16:14 |
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Basic information
Public title
The effects of inhibition and pain-improving in human endometriosis and in an endometriosis mouse model.
Acronym
The effects of isoflavones for endometriosis.
Scientific Title
The effects of inhibition and pain-improving in human endometriosis and in an endometriosis mouse model.
Scientific Title:Acronym
The effects of isoflavones for endometriosis.
Region
| Japan |
Condition
Condition
endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of aglycone isoflavones in patients with endometoriosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of visual analogue scale before and after administration of isoflavone.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subject patient is administered aglycone isoflavones at 30 mg / day for 3 months.
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with chronic pelvic pain whose VAS 2.0 or higher menstrual cycle days are within 25 to 38 days.
Key exclusion criteria
(1) Patients who used patients who had taken nutritional supplements containing soy isoflavone within 3 months of receiving visits
(2) Within 3 months of receiving visits, we used an analog formulation of GnRH, an endocrine formulation based on luteinizing hormone or follicle hormone, a low dose pill, a middle dose pill, a testosterone derivative and a Chinese medicine having indication for endometriosis patient
(3) Patients who underwent surgical treatment for endometriosis by vaginal alcohol fixation, laparotomy, laparoscopy within 3 months of receiving visits
(4) Patients who are suspected of being pregnant or pregnant at the time of visit
(5) At the time of consultation, a patient who is a nursing woman
(6) Patients judged inappropriate by the attending physician
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | JO |
| Middle name | |
| Last name | KITAWAKI |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
602-8566
Address
602-8566 Kyoto Japan
TEL
0752515560
takaoka@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | takaoka |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
602-8566
Address
602-8566 Kyoto Japan
TEL
0752515560
Homepage URL
takaoka@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
kyoto
Tel
075-252-5560
takaoka@koto.kpu-m.ac.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
| 2018 | Year | 03 | Month | 31 | 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
| 2018 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035490
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
