Clinical Study of UBPN01 to Evaluate Efficacy and Safety in women with Postmenopausal Syndrome

Not Applicable

Completed

• Conditions: Health Condition 1: N951- Menopausal and female climactericstates

• Registration Number: CTRI/2020/11/028988
• Lead Sponsor: DBIO Pharma Co Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-27
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Female between 40 to 60 years (both inclusive) of age at the time of enrolment.

2. Female who are in the state of menopause (amenorrhea for 12 consecutive months) or transition

to menopause (for FSH > 30 IU/L without menstruation for more than 3 months)

3. Female with moderate to severe menopausal symptoms (modified Kupperman Index total score

>= 25 point)

4. A person who agrees to participate in this study and signs a written consent

Exclusion Criteria

1.Women with a body mass index (BMI) greater than 30 kg / m2

2.Women undergoing HRT (Hormone Replacement Therapy) treatment to relieve menopausal symptoms within 1 month

3.Women taking the following food supplements to relieve menopausal symptoms within 1 month. The food can be a part of regular meal. Though, if any food is being used as a remedy or medication to relieve symptoms, it will be considered as exclusion criteria: Phytoestrogen containing food, Vitamins, Herb extract, Ginseng product, Omega 3, DHEA, Gamma linoleic acid.

4.Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast cancer or breast disease, sex hormone related cancer

5.A woman with a history of severe migraine within the past year or who has been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or underwent coronary angioplasty

6.Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants

7.Women with irregular uterine bleeding after 1 year of menopause

8.Patients with uncontrolled hypertension (160 /100mmHg or more, After 10 minutes of stabilization)

9.Uncontrolled diabetes mellitus patients (fasting blood sugar more than 180mg/dL or starting a new drug due to diabetes within 3 months)

10.Patients with thyroid disease whose TSH is less than or equal to 0.1 μU / ml or more than 10 μU / ml

11.drug or alcohol abuser

12.If ALT or AST exceeds 3 times the normal upper limit of the research institute

13.Creatinine exceeds twice the normal upper limit of research institute

14.If a clinically significant abnormality is confirmed by mammography (BI-RADS: Breast Imaging-Reporting and data system Category 0 or 3 or higher. However, in case of BI-RADS category 0, registration is possible at the discretion of the examiner)

15.Female with an endometrial thickness greater than 5mm by vaginal sonogram.

16.Have participated or planned to participate in other clinical trials within the past month

17.Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clopidogrel, etc.) within 3 months

18.Those taking or administering a therapeutic agent for osteoporosis, such as a bisphosphonate preparation

19.Those who investigator judges inappropriate to participate in this study. The reason for this consideration should be recorded in the source document.

Study & Design

• Study Type: Interventional
• Study Design: Not specified