JRCT ID: jRCTs031220256
Registered date:08/08/2022
Pyridoxamine for menopausal disorder
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | menopausal disorder with psychological symptoms |
Date of first enrollment | 19/10/2023 |
Target sample size | 50 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | After informed consent is obtained, patients are registered provisionally, and are orally administered 2 placebo capsules a day, each after breakfast and supper, for 2 weeks. Those who did not respond to the placebo capsules are definitely registered and allotted to either the test group or the control group. Participants in the test group are administered 1,200 mg (4 capsules) of pyridoxamine per day, 2 capsules each after breakfast and supper. The participants in the control group are administered 4 capsules of placebo, 2 capsules each after breakfast and supper. Both groups are administered either pyridoxamine or placebo for 6 weeks. |
Outcome(s)
Primary Outcome | Improvement in depressive symptoms (decrease in the CES-D score at week 6 compared to week 0) |
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Secondary Outcome | Improvement in vasomotor symptoms (decrease in the Hot Flash Severity Index from week 0 to week 6) Improvement in anxiety symptoms (decrease in the STAI score from week 0 to week 6) |
Key inclusion & exclusion criteria
Age minimum | >= 40age old |
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Age maximum | < 65age old |
Gender | Female |
Include criteria | [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 5. female 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. |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Terauchi Masakazu |
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Secondary Sponsor | |
Source(s) of Monetary Support | Renascience Inc.,Tokyo Medical and Dental University,Japan Agency for Medical Research and Development |
Secondary ID(s) |
Contact
Public contact | |
Name | Masakazu Terauchi |
Address | 1-5-45 Yushima Bunkyou-ku Tokyo Tokyo Japan 113-8519 |
Telephone | +81-3-5803-4605 |
teragyne@tmd.ac.jp | |
Affiliation | Tokyo Medical And Dental University |
Scientific contact | |
Name | Masakazu Terauchi |
Address | 1-5-45 Yushima Bunkyou-ku Tokyo Tokyo Japan 113-8510 |
Telephone | +81-3-5803-4605 |
teragyne@tmd.ac.jp | |
Affiliation | Tokyo Medical And Dental University-Hospital |