Explorative study on the effects of pyridoxamine in patients with menopausal disorder with psychological symptoms

Terauchi Masakazu0 个研究点目标入组 50 人开始时间: 2022年8月8日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•[provisional registration]
•Those who fulfill all the items below will be registered provisionally:
•1. those who have menopausal disorder with psychological symptoms by main doctor(excluding those who have symptoms due to cancer treatment)
•2. those who responded as either moderate or severe to any of the MHR-QOL items: #10 I feel less enthusiastic about things than before.; #11 Things I used to enjoy have become a bit of chore.; #12 I do less than I would like.; #16 I upset about small things.; #17 I feel nervous about small things.
•3. those who are aged 40 to 64 years old
•4. out-clinic patients
•6. those how are able to provide informed consent
•[definite registration]
•Those who fulfill the inclusion criteria item #2 after 2 weeks of placebo administration will be registered definitely.

•Those who fulfill any of the items below will be excluded from the trial.
•1. those who have depressive disorders not related to menopause
•2. those who have serious comorbidities, such as cancers, cardiac diseases, liver diseases, hematologic diseases, etc.
•3.those who were enrolled in another trial less than three months ago, or those who are going to be enrolled in another trial during the course of the current one
•4. those who were prescribed any of the incompatible drugs (estrogens, Kampo formulae, psychotropic agents, etc.) within the past 4 weeks
•5. those who have serious drug allergy
•6. those whose eGFR are less than 30 mL/min
•7. those whom the principal investigator or co-investigators consider to be incompatible

发起方

Terauchi Masakazu