UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041802
Receipt number 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 2024/03/18 10:22:27

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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

Obstetrics 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 or person

Institute

Bayer Yakuhin, Ltd.

Institute

Department

Personal name



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

495

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

Main results already published

Date of protocol fixation

2020 Year 09 Month 09 Day

Date of IRB

2020 Year 09 Month 18 Day

Anticipated trial start date

2020 Year 09 Month 18 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

2024 Year 03 Month 18 Day



Link to view the page

Value
https://center6.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