Tokyo, Sept. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063002) titled 'Intervention study using self-care management application for PMS' on Sept. 20.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Gifu University of Medical Science

Condition: Condition - premenstrual syndrome Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Verify the effectiveness of the PMS self-management app, which can positively record daily symptoms and help you respond to your symptoms. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants will use the PMS self-management support application 'MOON' for at least two menstrual cycles (approximately 2-3 months). The application enables participants to record and visualize their menstrual cycles and PMS symptoms and provides information on PMS and self-care strategies.

Eligibility: Age-lower limit - 19 years-old = Gender - Female Key inclusion criteria - 1.Women who have never given birth. 2.Women who experience psychological and/or physical symptoms before menstruation that improve or disappear after the onset of menstruation. 3.Women whose premenstrual symptoms have at least some impact on their daily lives. 4.Women who are able to use the 'MOON' application on a smartphone (iOS or Android). 5.Women who are able to use the application and complete the questionnaires in Japanese. 6.Women who understand the study and provide informed consent to participate. Key exclusion criteria - 1.Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. 2.Women who are amenorrheic or have markedly irregular menstrual cycles, making it difficult to use the application for at least two menstrual cycles during the study period. 3.Women who are currently receiving medical treatment for premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD). 4.Women who are deemed by the principal investigator to be unsuitable for participation in the study due to their health condition or other reasons. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 17 Day Date of IRB - 2026 Year 09 Month 15 Day Anticipated trial start date - 2026 Year 10 Month 09 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055133

Disclaimer: Curated by HT Syndication.