UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057719 |
|---|---|
| Receipt number | R000065945 |
| Scientific Title | Study to verify the effectiveness of Recovery Wear in alleviating menstrual pain |
| Date of disclosure of the study information | 2025/05/02 |
| Last modified on | 2025/04/24 16:55:26 |
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Basic information
Public title
Study to verify the effectiveness of Recovery Wear in alleviating menstrual pain
Acronym
Study to verify the effectiveness of Recovery Wear in alleviating menstrual pain
Scientific Title
Study to verify the effectiveness of Recovery Wear in alleviating menstrual pain
Scientific Title:Acronym
Study to verify the effectiveness of Recovery Wear in alleviating menstrual pain
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A placebo-controlled, randomized, double-blind, parallel-group study will be conducted in women with high dysmenorrhea score and degree of menstrual pain to investigate the effect of continuous use of the test product for approximately two weeks from one week before the scheduled start of menstruation to the end of menstruation to relieve menstrual pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Degree of menstrual pain( Numerical Rating Scale:NRS)
Key secondary outcomes
(1) DRSP Japanese version
(2) Dysmenorrhea score
(3) Analgesic use or not
(4) Short version of DRSP
(5) Questionnaire on physical symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Recovery wear (test product) worn from 7 days before the expected start of menstruation until the end of menstruation
Interventions/Control_2
Recovery wear(placebo product) worn from 7 days before the expected start of menstruation until the end of menstruation
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
| 19 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Women who are between 19 and 40 years of age at the time of obtaining consent to participate in the study
(2) Women who experience menstrual pain and take painkillers
(3) Subjects with regular menstrual cycles (25 to 38 days)
(4) Subjects who are able to agree to the subject management items
(5) Subjects who can consent to the use of the results of this study in a form that does not personally identify them for use in academic conferences, corporate advertisements, etc.
(6) The applicant must be fully informed of the purpose and content of this study, have the ability to consent, and be able to give his/her consent of his/her own free will after fully understanding the purpose and content of the study, and to give his/her consent by electromagnetic informed consent.
Key exclusion criteria
(1) currently receiving or planning treatment for dysmenorrhea, pms, pmdd, menopausal disorders, or other gynecological diseases
(2) currently receiving or planning treatment for psychiatric disorders (such as depression, anxiety, insomnia), thyroid disorders (such as graves disease, hashimoto disease), or autonomic nervous system disorders
(3) currently receiving or planning treatment for chronic diseases
(4) history of serious diseases such as cerebrovascular, cardiac, diabetic, hepatic, renal, gastrointestinal, or vascular disorders
(5) pregnant, possibly pregnant, postpartum, or breastfeeding
(6) taking oral contraceptives
(7) bmi of 25 or more
(8) participating in another clinical trial, or having participated or planning to participate within 4 weeks
(9) allergy or sensitivity to any component of the study product
(10) skin conditions (such as scars, eczema, inflammation, infection, or sunburn) on areas in contact with the product
(11) expected major lifestyle changes during the study (such as relocation, job transfer, or long travel)
(12) unable to discontinue supplements or herbal remedies for menstrual symptoms (such as magnesium, omega-3, vitamin d) during the study
(13) smoking 21 cigarettes or more per day
(14) consuming more than 60 grams of alcohol per day on 6 or more days per week
(15) extremely irregular eating habits (such as frequently skipping 2 or more meals or eating out almost daily)
(16) irregular lifestyle (such as shift work or working late at night)
(17) judged unsuitable by the study sponsor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Research Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Clinical Research Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japn
TEL
03-6716-0700
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
MTG Co., 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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
| 2025 | Year | 05 | Month | 02 | 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
| 2025 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065945
