Tokyo, July 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062351) titled 'A study of changes in body temperature, physical and mental condition, and blood components during the menstrual cycle' on July 27.

Study Type: Observational

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Menstrual-related symptoms Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To longitudinally collect core body temperature, physiological measurements, symptom assessments, and blood multi-omics data from women with menstrual-related symptoms and healthy women, and to identify molecular factors associated with physiological changes during the menstrual cycle. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old = Gender - Female Key inclusion criteria - Participants must meet all of the following criteria:

Premenopausal women aged 18 to 49 years Japanese nationals of Asian ethnicity Body weight of 40 kg or more Provision of written informed consent after receiving a sufficient explanation of the study No irregular menstrual cycles, defined as cycles of 24 days or shorter or 39 days or longer, with cycle-to-cycle variation of no more than 6 days Either of the following: Women diagnosed with menstrual-related symptoms Healthy women without a diagnosis of menstrual-related symptoms Key exclusion criteria - Participants meeting any of the following criteria will be excluded:

Clinically significant systemic diseases (e.g., hematologic, renal, pulmonary, or cardiovascular diseases) History of major trauma, surgery, or major bleeding within the past 3 months Pregnant, breastfeeding, or postmenopausal women Use of a pacemaker or implantable electrical medical device Scheduled MRI examination or air travel during the core body temperature monitoring period Judged unsuitable for participation by the principal investigator (e.g., severe sleep disorders, excessive stress, menopausal symptoms) Students or staff belonging to the investigators' laboratory, or students whose academic evaluation is conducted by the investigators Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 23 Day Date of IRB - 2026 Year 07 Month 23 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071360

Disclaimer: Curated by HT Syndication.