Unique ID issued by UMIN | UMIN000031295 |
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Receipt number | R000035726 |
Scientific Title | A double-blind, placebo-controlled study with A-2 on symptoms of vaginal atrophy in postmenopausal women |
Date of disclosure of the study information | 2021/05/01 |
Last modified on | 2018/02/14 10:43:55 |
A double-blind, placebo-controlled study with A-2 on symptoms of vaginal atrophy in postmenopausal women
Effect of A-2 on symptoms of vaginal atrophy in postmenopausal women
A double-blind, placebo-controlled study with A-2 on symptoms of vaginal atrophy in postmenopausal women
Effect of A-2 on symptoms of vaginal atrophy in postmenopausal women
Japan |
Healthy postmenopausal women
Adult |
Others
NO
In this study, we investigate the symptoms of vaginal atrophy after ingestion of A-2 or placebo for 12 weeks in postmenopausal women.
Safety,Efficacy
The symptoms of vaginal atrophy after ingestion for 12 weeks
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
1 time or 2 times/day, for 12 weeks
1 time or 2 times/day, for 12 weeks
45 | years-old | <= |
65 | years-old | > |
Female
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
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
50
1st name | |
Middle name | |
Last name | Kiyoshi Takamatsu |
Department of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital
Professor
5-11-13, Sugano, Ichikawa-city, Chiba
047-322-0151
ktakamatsu@tdc.ac.jp
1st name | |
Middle name | |
Last name | Shigeto Uchiyama |
Otsuka Pharmaceutical Co., Ltd.
Saga Nutraceuthicals Research Institute
5006-5 Yoshinogari, Kanzaki-gun, Saga
0952-52-1522
Uchiyama.Shigeto@otsuka.jp
Department of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital
Otsuka Pharmaceutical Co., Ltd.
Profit organization
NO
2021 | Year | 05 | Month | 01 | Day |
Unpublished
Preinitiation
2017 | Year | 12 | Month | 04 | Day |
2018 | Year | 02 | Month | 21 | Day |
2018 | Year | 02 | Month | 14 | Day |
2018 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035726
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