UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019193 |
|---|---|
| Receipt number | R000021543 |
| Scientific Title | Clinical trial of SR-16234 in patients with endometriosis. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2017/04/03 08:34:09 |
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Basic information
Public title
Clinical trial of SR-16234 in patients with endometriosis.
Acronym
Clinical trial of SR-16234 in patients with endometriosis.
Scientific Title
Clinical trial of SR-16234 in patients with endometriosis.
Scientific Title:Acronym
Clinical trial of SR-16234 in patients with endometriosis.
Region
| Japan |
Condition
Condition
Endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of SR-16234 in patients with endometriosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pelvic pain
Key secondary outcomes
Algomenorrhea, objective, adverse experience
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
| Medicine |
Interventions/Control_1
Once-daily oral administration of SR-16234 for 12 weeks
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patient wiht menstrual cycle
2) Patient with diagnosis of chocolate cyst of the ovary by echography or MRI
3) Patient with pelvic pain associated with endometriosis
Key exclusion criteria
1) Patient with estrogen-dependent cancer or cervical cancer
2) Patient with diagnosis of fibroid (longest diameter > 3 cm)
3) Patient with non-diagnosis of abnormal genital bleeding
4) Patinet with medical history of osteoporosis, bone loss or other metabolic disease
5) Treatment with luteal hormone or follicular hormone-based hormone agents, low dose pill, middle dose pill, GnRH agonist, testosterone derivative, follicular hormone antagonist, or aromatase inhibitor within 2 months of initiation of administration
6) Treatment with transvaginal alcohol fixative, surgical therapy by laparotomy or laparoscope within 3 months of initiation of administration
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tasuku Harada |
Organization
Tottori University Hospital
Division name
Devision of reproductive-perinatal and gynecologic oncology
Zip code
Address
36-1 Nishicho, Yonago, Tottori
TEL
0859-38-6641
tasuku@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuminori Taniguchi |
Organization
Tottori University Hospital
Division name
Devision of reproductive-perinatal and gynecologic oncology
Zip code
Address
36-1 Nishicho, Yonago, Tottori
TEL
0859-38-6647
Homepage URL
http://obgyn.med.tottori-u.ac.jp/index.html
tani4327@grape.med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
NobelPharma
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
Address
Tel
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
鳥取大学医学部附属病院（鳥取県）、倉敷平成病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 01 | Day |
Last modified on
| 2017 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021543
| 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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