UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009191 |
|---|---|
| Receipt number | 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 11:05:42 |
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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
| Obstetrics 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
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
Public contact
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010792
