UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of nonbenzodiazepine, melatonin receptor agonist, and Kampo medication on sleep disturbances in perimenopausal and postmenopausal women
Title of the study (Brief title)	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	Obsterics 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	Masakazu Terauchi
Organization	Tokyo Medical and Dental University
Division name	Department of Obstetrics and Gynecology
Address	Yushima 1-5-45, Bunkyo, Tokyo
TEL	03-3813-6111
Email	teragyne@tmd.ac.jp

Public contact
Name of contact person	Masakazu Terauchi
Organization	Tokyo Medical and Dental University
Division name	Department of Obstetrics and Gynecology
Address	Yushima 1-5-45, Bunkyo, Tokyo 113-8510, Japan
TEL	03-3813-6111
Homepage URL
Email	m.terauchi.gyne@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 04 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006947