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An Exploratory Clinical Study to Investigate the Association Between Violet Light (VL) and the Menstrual Cycle in Subjects With Menstrual Irregularities

An Exploratory Clinical Study to Investigate the Association Between Violet Light (VL) and the Menstrual Cycle in Subjects With Menstrual Irregularities

Suzuki Ayako

Medical Corporation Association Yukari-kai Toranomon Women's Clinic

1-1-18 Toranomon, Minato-ku, Tokyo Hulic Toranomon Building 1st floor

akmskorokoro@gmail.com

Suzuki Ayako

Medical Corporation Association Yukari-kai Toranomon Women's Clinic

1-1-18 Toranomon, Minato-ku, Tokyo Hulic Toranomon Building 1st floor

+81-3-3502-1211

toranomon_study@yahoo.co.jp

Complete

Oct. 10, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Subjects who meet all of the following conditions will be included in this study:
1)Subjects who are aged 20 over and 40 under years old at the time of obtaining consent.
2)Subjects who have menstrual irregularities prior to obtaining consent*
*Subjects whose menstrual cycle does not fall into the normal cycle (25~38 days)
3)Subjects who have had menstrual irregularities in the last 3 months from the interview or the patient's record
4)Subjects who are able to spend time with the naked eye or contact lenses that meet certain conditions** while wearing the research equipment.
** VL transmissive contact lenses can be used, but UV-protected contacts
Lenses and colored contact lenses are not allowed.
5)Subjects who have voluntarily given written consent to participate in this study
6)Subjects who have been fully briefed on the matters to be complied with in this clinical trial, are willing to comply with the contents, and are able to comply with them.

Subjects who fall under any of the following will be excluded from the study:
1)Subjects with a positive pregnancy test at screening
2)Subjects with abnormalities in the retina confirmed by ophthalmologic examination at screening
3)Subjects with a history of ophthalmic surgery within 6 months prior to obtaining consent
4)Subjects with organic diseases such as pituitary amenorrhea, ovarian amenorrhea, thyroid dysfunction, and hyperprolactinemia.
5)Subjects who have undergone or are undergoing treatment for ovulation induction and hormone therapy
However, among subjects who have undergone ovulation induction or hormone therapy, if they have not been treated for more than 2 months before obtaining consent and are considered to be unaffected by drugs, etc., they may be registered at the discretion of the principal investigator.
6)Subjects taking oral contraceptives
7)Pregnant or lactating Subjects
8)Subjects who have been diagnosed with neurogenic eating disorders (anorexia nervosa and bulimia nervosa)
9)Subjects who abuse or become dependent on drugs
10)Subjects who abuse or depend on alcohol
11)Subjects with serious heart disease, liver disease, renal disease, respiratory failure
12)Subjects with a history of seizures or epilepsy
13)Subjects with malignant tumors or a history within 5 years prior to obtaining consent
14)Immunocompromised Subjects or Subjects with a history of HIV infection
15)Other Subjects who are judged to be inappropriate by the principal investigator , etc., such as those who are judged by the doctor to have a history of treatment or a disease that may affect the menstrual cycle.

Female

Menstrual irregularities

Wearing violet light irradiation glasses

Changes in the menstrual cycle (the number of days from the start date of menstruation to the day before the start of the next menstrual period) over time

1.Evaluation of subjective symptoms (NRS) at each time point
2.Evaluation of each time point of the questionnaire

+81-3-3470-3360

No

None