UMIN-CTR Clinical Trial

Public title

Clinical study on the efficacy and safety of EstroG-100J for menopausal symptoms: randomized double-blinded controlled study

Acronym

Efficacy and safety of EstroG-100J

Scientific Title

Clinical study on the efficacy and safety of EstroG-100J for menopausal symptoms: randomized double-blinded controlled study

Scientific Title:Acronym

Efficacy and safety of EstroG-100J

Region

Japan

Condition

Menopausal symptoms

Classification by specialty

Medicine in general	Obstetrics and Gynecology	Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Naoyuki Kamatani

Organization

Tsukuba International Clinical Pharmacology Clinic

Division name

Management Office of Clinical Trials

Zip code

Address

1-21-16 Kan-nondai, Tsukuba-city, Ibaragi-prefecture, Post code 305-0856

TEL

029-839-1150

Email

n-kamatani@tsukuba-icp.jp

Name of contact person

1st name
Middle name
Last name	Masaki Suzuki

Organization

Tsukuba International Clinical Pharmacology Clinic

Division name

Volunteer Department

Zip code

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

Institute

Tsukuba International Clinical Pharmacology Clinic

Institute

Department

Personal name

Organization

Naturalendo Tech Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

12

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

11

Month

19

Day

Date of IRB

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

Other related information

Registered date

2014

Year

12

Month

16

Day

Last modified on

2018

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018381