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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009191
Receipt No. R000010792
Scientific Title Effects of oral contraceptive pills on sleep disturbances in young women with primary dysmenorrhea
Date of disclosure of the study information 2012/11/01
Last modified on 2015/09/26

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Basic information
Public title Effects of oral contraceptive pills on sleep disturbances in young women with primary dysmenorrhea
Acronym Effects of oral contraceptive pills on sleep disturbances in young women with primary dysmenorrhea
Scientific Title Effects of oral contraceptive pills on sleep disturbances in young women with primary dysmenorrhea
Scientific Title:Acronym Effects of oral contraceptive pills on sleep disturbances in young women with primary dysmenorrhea
Region
Japan

Condition
Condition primary dysmenorrhea
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of two types of oral contraceptives on sleep disturbances in young women with primary dysmenorrhea
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes subjective and objective sleep parameters
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 8-week treatment with drospirenone/ethinylestradiol
Interventions/Control_2 8-week treatment with norethisterone/ethinylestradiol
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
40 years-old >
Gender Female
Key inclusion criteria women diagnosed with primary dysmenorrhea
Key exclusion criteria (1)estrogen-dependent tumors
(2)abnormal uterine bleeding
(3)cardiovascular diseases
(4)valvular heart diseases
(5)hypertension
(6)diabetes
(7)dyslipidemia
(8)venous thromboembolism
(9)migraine
(10)severe liver or kidney dysfunction
(11)smoking women
(12)pregnant or lactating women
(13)women who have been already treated for sleep or mood disturbances
(14)severe cognitive impairment
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masakazu Terauchi
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Zip code
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Zip code
Address teragyne@tmd.ac.jp
TEL
Homepage URL
Email

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)

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
2012 Year 11 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 Terminated
Date of protocol fixation
2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 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
2012 Year 10 Month 26 Day
Last modified on
2015 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010792

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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