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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name