Hormone Estradiol Replacement Therapy Additional Herbals

NCT02618148 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Estrogen Herbals
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to determine whether Hormone Replacement Therapy (HRT), safety studies are combined with herbal (garlic oil, rutin, and nattokinase) to reduce estrogen side effects. Making it safer when an endocrine supplement is needed for estrogen deficiency symptoms in menopausal and postmenopausal women.

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• Time to Estradiol > 35 pg / ml

  * Patients fulfilling inclusion and exclusion criteria. * Measure the time to Estradiol \> 35 pg / ml * Will be divided into two groups Group (A): Females premenopausal Group (B): Females postmenopausal * Females premenopausal: (Reference Range: (35-525 pg/mL) * Females postmenopausal: (Reference Range:(0-35 pg/mL)

  1 years

Secondary Outcomes (1)

• Time to Estradiol > 35 pg / ml

  2 years

Study Arms (2)

ESTROGEN HERBALS 21

EXPERIMENTAL

Used for women who wish to monthly menstruation Applies to the following strengths: 17β-estradiol 1.5mg/24 hours x 21 days, stop drinking for 7 days. Progesterone 5mg/24 hours x 10 days, stop drinking for 7 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.

Drug: ESTROGEN HERBALS 21

ESTROGEN HERBALS 28

EXPERIMENTAL

Used for women who do not wish to monthly menstruation Applies to the following strengths: 17β-estradiol 1.5mg/24 hours x 28 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.

Drug: ESTROGEN HERBALS 28

Interventions

ESTROGEN HERBALS 21 DRUG

Applies to the following strengths: 17β-estradiol 1.5mg/24 hours x 21 days, stop drinking for 7 days. Progesterone 5 mg/24 hours x 10 days, stop drinking for 7 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.

Also known as: EPGANA 21

ESTROGEN HERBALS 21

ESTROGEN HERBALS 28 DRUG

Applies to the following strengths: 17β-estradiol 1.5mg/24 hours x 28 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.

Also known as: EPGANA 28

ESTROGEN HERBALS 28

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in perimenopausal and postmenopausal women.
• Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

You may not qualify if:

• Known, past or suspected breast cancer;
• Known or suspected oestrogen-dependent malignant tumours (eg endometrial cancer);
• Undiagnosed genital bleeding;
• Untreated endometrial hyperplasia;
• Previous or current venous thromboembolism (deep venous thrombosis,pulmonary embolism)
• Known thrombophilic disorders (eg protein C, protein S, or antithrombin deficiency, see section.
• Active or recent arterial thromboembolic disease (eg angina, myocardial infarction);
• Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;
• Known hypersensitivity to the active substances or to any of the excipients;

Sponsors & Collaborators

• Trieu, Nguyen Thi, M.D.: lead

Study Sites (2)

Saigon Biopharma LLC

Wilmington, Delaware, 19801-6601, United States

Location

Saigon Biopharma Company Limited

Ho Chi Minh City, 700000, Vietnam

Location

Related Links

• Garlic Oil
• Nattokinase
• Progesterone
• Estradiol

Study Officials

• Tran Minh Cam Tu, Dr.

  Nguyen Thi Trieu, Dr.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: November 14, 2015
• First Posted: December 1, 2015
• Study Start: January 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

VN (1); US (1)