UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A double-blind, placebo-controlled study with A-2 on symptoms of vaginal atrophy in postmenopausal women
Title of the study (Brief title)	Effect of A-2 on symptoms of vaginal atrophy in postmenopausal women
Region	Japan

Condition
Condition	Healthy postmenopausal women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we investigate the symptoms of vaginal atrophy after ingestion of A-2 or placebo for 12 weeks in postmenopausal women.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The symptoms of vaginal atrophy after ingestion for 12 weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1 time or 2 times/day, for 12 weeks
Interventions/Control_2	1 time or 2 times/day, for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key 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
Key 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
Target sample size	50

Research contact person
Name of lead principal investigator	Kiyoshi Takamatsu
Organization	Department of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital
Division name	Professor
Address	5-11-13, Sugano, Ichikawa-city, Chiba
TEL	047-322-0151
Email	ktakamatsu@tdc.ac.jp

Public contact
Name of contact person	Shigeto Uchiyama
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Saga Nutraceuthicals Research Institute
Address	5006-5 Yoshinogari, Kanzaki-gun, Saga
TEL	0952-52-1522
Homepage URL
Email	Uchiyama.Shigeto@otsuka.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 04 Day
Anticipated trial start date	2018 Year 02 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 14 Day
Last modified on	2018 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035726