Healthy postmenopausal women
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Duration of amenorrhea; >2 y and <5 y 2) Serum estradiol concentration; <21 pg/mL 3) Serum FSH concentration; >30 mIU/mL 4) The symptoms of vaginal atrophy 5) BMI; >18.5 and <30 kg/m2 6) No medication for menopausal symptoms 7) No OTC medical agents or health foods for relief of menopausal symptoms
Exclusion criteria
Exclusion criteria: 1) Diversity from normal ranges of vital signs, and in clinical laboratory tests 2) Current or past reproductive-related cancer and so forth 3) Serious illumes 4) Allergies to soy or lactose 5) Individuals who are diagnosed as inappropriate for the trial by the principal Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The symptoms of vaginal atrophy after ingestion for 12 weeks | — |
Countries
Japan
Contacts
Otsuka Pharmaceutical Co., Ltd. Saga Nutraceuthicals Research Institute