UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005882 |
|---|---|
| Receipt number | R000006947 |
| Scientific Title | Effects of nonbenzodiazepine, melatonin receptor agonist, and Kampo medication on sleep disturbances in perimenopausal and postmenopausal women |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2018/01/04 14:46:34 |
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Basic information
Public title
Effects of nonbenzodiazepine, melatonin receptor agonist, and Kampo medication on sleep disturbances in perimenopausal and postmenopausal women
Acronym
Effects of nonbenzodiazepine, melatonin receptor agonist, and Kampo medication on sleep disturbances in perimenopausal and postmenopausal women
Scientific Title
Effects of nonbenzodiazepine, melatonin receptor agonist, and Kampo medication on sleep disturbances in perimenopausal and postmenopausal women
Scientific Title:Acronym
Effects of nonbenzodiazepine, melatonin receptor agonist, and Kampo medication on sleep disturbances in perimenopausal and postmenopausal women
Region
| Japan |
Condition
Condition
climacteric syndrome
insomnia
Classification by specialty
| Obstetrics and Gynecology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of nonbenzodiazepine, melatonin receptor agonist, Kampo medication on sleep disturbances in perimenopausal and postmenopausal women
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective and objectivd sleep parameters
Key secondary outcomes
menopausal symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
4-week treatment with zolpidem 5 mg/day
Interventions/Control_2
4-week treatment with ramelteon 8 mg/day
Interventions/Control_3
4-week treatment with yokukansan 7.5 g/day
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
women who visit our menopause clinic and have moderate to severe sleep disturbances
Key exclusion criteria
(1) those who receive fluvoxamine (2) those who have severe liver damage (3) those who have severly impaired lung function (4) those who have myasthenia gravis (5) those who have acute angle-closure glaucoma
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-3813-6111
teragyne@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Yushima 1-5-45, Bunkyo, Tokyo 113-8510, Japan
TEL
03-3813-6111
Homepage URL
m.terauchi.gyne@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | 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
| 2011 | Year | 06 | Month | 29 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006947
