UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study on the efficacy and safety of EstroG-100J for menopausal symptoms: randomized double-blinded controlled study
Title of the study (Brief title)	Efficacy and safety of EstroG-100J
Region	Japan

Condition
Condition	Menopausal symptoms
Classification by specialty	Medicine in general Obsterics and gynecology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of EstroG-100J on menopausal symptoms of pre-, peri- and post- menopausal women.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference of the mean change of Kupperman's menopausal index (KMI) (from week 0 to 8) between placebo and EstroG-100J groups
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	EstroG-100J
Interventions/Control_2	Placebo
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) Subjects with abilities to present consent who have been informed of the objectives and the contents of the present clinical trial, have sufficiently understood them, and have voluntarily expressed the consent by written documents. 2) Japanese adult females with pre-, peri- and post-menopausal symptoms. 3) Females with Kupperman's menopausal index (KMI) of not lower than 20.
Key exclusion criteria	1) Subjects with BMI of over 28. 2) Subjects who are treated for menopausal disorders (including those taking dietary supplements). 3) Subjects who either took foods or dietary supplements, or were treated with either oral or topical drugs containing estrogen or progesterone within 3 months before the informed consent. 4) Subjects with breast cancers, uterine cancers, ovary cancers or female-hormone-dependent cancers (including suspected cases), or those with histories of those diseases. 5) Subjects having first-degree family members with breast cancers or the histories of breast cancers. 6) Subjects with the histories of ovarian surgeries. 7) Subjects taking psychotropic drugs or drugs with psychological effects. 8) Subjects with psychological disorders or with the histories of those disorders. 9) Subjects with abnormal vaginal bleeding for more than one year after the menopause. 10) Subjects who have undergone hysterectomy. 11) Subjects with not-well-controlled hypertension. 12) Subjects with thyroid disorders. 13) Subjects with diabetes mellitus. 14) Subjects with coagulation disorders such as deep-vein thrombosis. 15) Subjects with abnormalities in either renal or liver function tests. 16) Subjects with either drug addiction or alcoholism. 17) Subjects who are judged to be inappropriate for the trial by either primary or other investigators.
Target sample size	60

Research contact person
Name of lead principal investigator	Naoyuki Kamatani
Organization	Tsukuba International Clinical Pharmacology Clinic
Division name	Management Office of Clinical Trials
Address	1-21-16 Kan-nondai, Tsukuba-city, Ibaragi-prefecture, Post code 305-0856
TEL	029-839-1150
Email	n-kamatani@tsukuba-icp.jp

Public contact
Name of contact person	Masaki Suzuki
Organization	Tsukuba International Clinical Pharmacology Clinic
Division name	Volunteer Department
Address	1-21-16 Kan-nondai, Tsukuba-city, Ibaragi-prefecture, Post code 305-0856
TEL	029-839-1150
Homepage URL
Email	m-suzuki@tsukuba-icp.jp

Sponsor
Institute	Tsukuba International Clinical Pharmacology Clinic
Institute
Department

Funding Source
Organization	Naturalendo Tech 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	2014 Year 12 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 19 Day
Anticipated trial start date	2015 Year 01 Month 10 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	2014 Year 12 Month 16 Day
Last modified on	2018 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018381