Clinical trial for predicting menstrual period

UMIN ID: UMIN000055649

Registered date:29/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: healthy adult
• Date of first enrollment: 2024/10/03
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The test product is used daily from 7 days before the expected start of menstruation until the onset of menstruation. Perform 2 cycles.

Outcome(s)

• Primary Outcome: Measurement of protein in the discharge Results of the survey

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 55years-old
• Gender: Female
• Exclude criteria: (1) Subjects with a history of 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) Subjects with a diagnosis of endometrial disease (8) Subjects with excessive irregular bleeding (9) Subjects with a history of mental disease (10) Women undergoing infertility treatment and those who have been diagnosed with polycystic ovary syndrome (11) 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 (12) Subjects less than 1 year postpartum (13) Subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (14) Subjects or a close family member who works for Cranebio Co., Ltd., Unicharm Co., Ltd., or their affiliates. (15) Subjects who play intense sports and subjects who are on a diet (16) Subjects with extremely irregular eating habits (17) 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 (18) Subjects who are continuously receiving medical treatment (including OTC and prescription drugs) (19) Subjects taking pills for menstrual regulation (20) Subjects who drink more than 60 g of average daily pure alcohol (21) Subjects who smoke an average of 21 or more cigarettes a day (22) and (23) are listed in the "Other related infrmation" column.

Related Information

• Primary Sponsor: Miura Clinic, Medical Corporation Kanonkai
• Source(s) of Monetary Support: Cranebio Co., Ltd.