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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031074
Receipt No. 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 2018/01/31

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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
Obsterics 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
Middle name
Last name Jo Kitawaki
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Obstetrics and Gynecology
Zip code
Address 602-8566 Kyoto Japan
TEL 075-251-5560
Email takaoka@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Takaoka
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Obstetrics and Gynecology
Zip code
Address 602-8566 Kyoto Japan
TEL 075-251-5560
Homepage URL
Email takaoka@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department

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
Address
Tel
Email

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
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
2018 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035490

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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