late onset hypogonadism syndrome(LOH)
Conditions
Interventions
A tablet containing 10 mg of 5-aminolevulinic acid phosphate was administered 3 tablet daily for 8 weeks
placebo tablet intake group for 8 weeks
Sponsors
Juntendo University, Graduate School of Medicine, Department of Urology
Juntendo University Urayasu Hospital, Teikyo University School of Medicine affiliated hospital, Men'
s Health Clinic Tokyo
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese male aged between 35 and 75 years old at the time of acquiring consent document of participation in the examination 2) men who have consciousness of indefinite complaint of menopausal male 3) AMS score of 27 points or more and less than 50 points 4) Those who have sufficient explanation about the purpose and contents of this exam, who have the capacity to consent, voluntarily volunteer for participation after understanding well, who can agree to participate in this study in writing 5) Men who can come to the designated examination date and receive examination 6) Men who the examination responsible doctor deems appropriate participation in this exam
Exclusion criteria
Exclusion criteria: 1) Those who have had medical history of malignancy in the past 3 years 2) People who has a history history of heart failure, renal failure, hepatitis B, hepatitis C, current medical history 3) People whose AST (GOT), ALT (GPT) is 1.5 times or more the upper limit of the reference value 4) People whose PSA value is 4.0 ng / mL or more 5) People who have experienced severe allergic symptoms in foods and medicines 6) Health function foods (foods for specified health use, etc.), health foods, supplements with continuous ingestion habits, those who intend to intake during the examination period 7) People who judged that doctor is inappropriate as subject of this exam
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total serum testosterone Testosterone in saliva Sperm examination findings | — |
Secondary
| Measure | Time frame |
|---|---|
| AMS score (Aging males' symptoms score) SF-36v2 IIEF score Regarding safety, blood biochemical tests, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactYoshiaki Wakumoto
Juntendo University, Graduate School of Medicine Department of Urology
Outcome results
None listed