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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041802
Receipt No. R000047716
Scientific Title A prospective observational study on menstrual symptoms, HRQoL, and work productivity in patients with primary or secondary dysmenorrhea before, during, and after treatment with LEP or non-LEP in Japan
Date of disclosure of the study information 2020/09/15
Last modified on 2020/09/15

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Basic information
Public title A prospective observational study on menstrual symptoms, HRQoL, and work productivity in patients with primary or secondary dysmenorrhea before, during, and after treatment with LEP or non-LEP in Japan
Acronym A prospective observational study on menstrual symptoms, HRQoL, and work productivity in patients with primary or secondary dysmenorrhea before, during, and after treatment with LEP or non-LEP in Japan
Scientific Title A prospective observational study on menstrual symptoms, HRQoL, and work productivity in patients with primary or secondary dysmenorrhea before, during, and after treatment with LEP or non-LEP in Japan
Scientific Title:Acronym A prospective observational study on menstrual symptoms, HRQoL, and work productivity in patients with primary or secondary dysmenorrhea before, during, and after treatment with LEP or non-LEP in Japan
Region
Japan

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

Objectives
Narrative objectives1 To describe changes in menstrual symptoms, HRQoL, and work productivity before and after treatment in dysmenorrhea patients treated with LEP
Basic objectives2 Others
Basic objectives -Others 1) To describe patients' background and medical history of dysmenorrhea patients treated with LEP and Non-LEP such as NSAIDs and TCM
2) To investigate menstrual symptoms, HRQoL, and work productivity at baseline and treatment period in Non-LEP cohort as well as patients' background and medical history as a reference
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The changes in the modified Menstrual Distress Questionnaire (mMDQ), the Short Form (36) Health Survey version 2 (SF-36v2), and the modified Work Productivity and Activity Impairment Questionnaire (mWPAI) after the treatment in patients treated with LEP, compared with before treatment.
Key secondary outcomes 1) Patient background and medical history in patients treated with LEP and Non-LEP at baseline.
2) The changes in the mMDQ, SF-36v2, and mWPAI after the treatment in patients treated with Non-LEP, compared with before treatment.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
16 years-old <=
Age-upper limit
39 years-old >=
Gender Male and Female
Key inclusion criteria Patients who meet all the inclusion criteria will be enrolled in this study.

1) Patients between the ages of 16 and 39
2) Patients diagnosed with primary or secondary dysmenorrhea by gynecologists
3) Patients who can visit ob/gyn clinics or hospitals every 6 months to have consultations with gynecologists for treatment of dysmenorrhea
4) Patients who plan to be treated with drug for dysmenorrhea after enrollment in this study
5) Patients who can access the website to complete the questionnaire using mobile communication equipment such as mobile phones or tablets
6) Patients who submit an informed consent on the website before the start of this study
Key exclusion criteria Patients who meet any of the exclusion criteria will not be enrolled in this study.

1) Patients who have taken LEP for dysmenorrhea in the last 2 months before enrollment
2) Patients with mental disorders such as depression, severe infectious diseases, or malignant tumors
3) Patients with contraindications for LEP or COC
4) Patients who deemed by the investigators to be unsuitable for inclusion in the study (e.g., patients using hormonal agents other than LEP)
Target sample size 350

Research contact person
Name of lead principal investigator
1st name Yasuko
Middle name
Last name Aitoku
Organization Bayer Yakuhin, Ltd.
Division name Market Access
Zip code 530-0001
Address 2-4-9 Umeda, Kita-ku, Osaka City, Osaka, Japan
TEL 06-6133-6397
Email yasuko.aitoku@bayer.com

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Mizukami
Organization Mebix, Inc.
Division name Research Promotion Division and Research Planning Group
Zip code 105-0001
Address Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo, Japan
TEL 03-4362-4500
Homepage URL
Email mizukami@mebix.co.jp

Sponsor
Institute Bayer Yakuhin, Ltd.
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Takahashi Clinic
Address 5-1-31 Iwayakita-machi, Nada-ku, Kobe City, Hyogo, Japan
Tel 078-882-6432
Email kishimoto.satoshi@neues.co.jp

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
2020 Year 09 Month 15 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 16 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Study visits were defined as Enrollment (Day 1), Follow-up time (Day 60), and Final follow-up time (Day 120) with an observational period of 120 days.
The data to be collected in this study are as follows; patients background, follow-up data such as treatment of dysmenorrhea and menstruation-related information, and questionnaire such as mMDQ, SF-36v2, and mWPAI-GH.

Management information
Registered date
2020 Year 09 Month 15 Day
Last modified on
2020 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047716

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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