Hormone Estradiol Replacement Therapy Additional Herbals

What this trial studies

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 in scope

• Menopause

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…
• 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.

Who can join

Women only · Ages 35 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• 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.

Exclusion criteria

• 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;

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE4
• Start date: 2009-01
• Primary completion: 2015-06
• Last update posted: 2025-05-16
• First posted: 2015-12-01

Sponsor & contact

Lead sponsor: Trieu, Nguyen Thi, M.D. (Indiv)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Time to Estradiol > 35 pg / ml (1 years)
  * 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)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.