CompletedPhase 4

Hormone Estradiol Replacement Therapy Additional Herbals

Vietnam60 participantsStarted 2009-01

Plain-language 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.

Who can participate

Age range

35 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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; * Known hypersensitivity to the active substances or to any of the excipients;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Estradiol > 35 pg / ml

Timeframe: 1 years

Trial details

NCT IDNCT02618148

SponsorTrieu, Nguyen Thi, M.D.

Sponsor typeINDIV

Study typeINTERVENTIONAL

Primary completion2015-06

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