Tokyo, Feb. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060296) titled 'Study on the use of panty liner ovulation test kits and cervical Swab kits' on Feb. 2.

Study Type: Interventional

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

Primary Sponsor: Institute - Miura Clinic, Medical Corporation Kanonkai

Condition: Condition - healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the concordance between biomarker response induced by the test products use and ovulation test results, and sensitivity of the cervical swab kit Basic objectives2 - Others

Intervention: Interventions/Control_1 - Panty liner ovulation test kits are used by 33 study participants, of whom 22 use cervical swab kits.

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - (1) Subjects of women having period aged 20 to 40 (2) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing Key exclusion criteria - (1) Subjects with a history of mental disorders, diabetes, liver disease, renal disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious disease (2) Subjects who have undergone surgery on the digestive organs (3) Subjects with abnormal liver function and renal function test values (4) Subjects with diseases currently being treated (5) Subjects who are allergic to foods and drugs (6) Subjects with anemia symptoms (7) Women undergoing infertility treatment and those who have been diagnosed with polycystic ovary syndrome (8) Use of hormonal contraceptives, use of hormone replacement therapy, fertility drugs, artificial insemination, IVF, ICSI Those who are undergoing other medical treatments, such as adjuvant fertility therapy. (9) Subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (10) Subjects or a close family member who works for Cranebio Co., Ltd., Unicharm Co., Ltd., or their affiliates. (11) Subjects who play intense sports and subjects who are on a diet (12) Subjects with extremely irregular eating habits (13) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (14) Subjects who are continuously receiving medical treatment (including OTC and prescription drugs) (15) Subjects who drink more than 60 g of average daily pure alcohol (16) Subjects who smoke an average of 21 or more cigarettes a day (17) Subjects who are participating in or will participate in other clinical trials at the start of this study (18) Other subjects judged by the investigator or the investigator to be inappropriate for the examination Target Size - 33

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 25 Day Date of IRB - 2025 Year 09 Month 25 Day Anticipated trial start date - 2026 Year 02 Month 03 Day Last follow-up date - 2026 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068232

Disclaimer: Curated by HT Syndication.