Hormone Estradiol Replacement Therapy Additional Herbals

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trieu, Nguyen Thi, M.D.
• Treatments: Allyl sulfide; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate; Polystyrene sulfonic acid

Criteria

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;