Please select the eligibility criteria that correspond to the clinical trial below.
Title: Herbal Alternatives for Menopause Symptoms: A Randomized Trial
Brief Summary: Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms.

The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.


Options:
A: Inclusion Criteria:

* Must be able to swallow the pills
* No menses for 12 months
* Blood follicle stimulating hormone great than 30 IU/mL
* Lumbar spine bone mineral density t-score equal to or greater than -1.5

Exclusion Criteria:

* Strict vegetarians
* Current or recent smokers (within last five years)
* Abnormal screening mammogram, Pap smear and blood chemistries
* Clinical diagnosis of osteoporosis, spine and/or hip fracture, cancer, liver, kidney, gallbladder and heart disease
* Clinical diagnosis of psychiatric disorder
* Any allergic reactions to soy products
* Current treatment with bisphosphonates, calcitonin, fluoride, corticosteroids, tamoxifen, raloxifene, HRT, premarin, farestron and letrozole
* Current usage of black cohosh, blue cohosh, dong quai, Caltrate 600+Soy, Estroven, ginseng, Healthy Women, Natural Estrogen, Opti-Soy, PhytoFem, Probalance, Promensil, Remifemin, Rimostil and Trinovin
B: Inclusion Criteria:

* female
* age 45 - 55
* peri- or post-menopausal
* moderate to severe vasomotor symptoms
* normal thyroid stimulating hormone
* proof of normal mammogram within past 2 years

Exclusion Criteria:

* use of HT or oral contraceptives within past 3 months
* use of herbs or alternative or complementary medicines for vasomotor symptoms within past 1 month
* medical history of contraindications to HT
* bone mineral density greater than 2 standard deviations below age specific mean
* bilateral oophorectomy
* current use of tamoxifen, raloxifene, bisphosphonates, cholesterol-lowering medications, prescription blood-thinners, or oral steroids
* pregnant or planning to become pregnant
* allergy to soybeans or soy protein
* unable to swallow pills
* current participation in another investigational drug trial
* intention to move out of area in the next 12 months
* non-compliance with procedures involved in screening and run-in trial
C: Postmenopausal women ages 50 to 79.
D: Inclusion Criteria

* Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L

Exclusion Criteria

* Treatment with estrogens, progesterone, raloxifene, or tamoxifen
* Treatment with bisphosphonates, calcitonin, fluoride, or systemic corticosteroids
* Use of soy/herbal supplements, including DHEA, within 3 months prior to study entry
* Use of antibiotics in the month prior to study entry
* Use of prescription medication to treat hot flashes
* Chemical menopause, including post-chemotherapy
* Hyperthyroidism
* Hypothyroidism
* Uncontrolled diabetes
* Malabsorption syndromes or other chronic diseases
* Body mass index (BMI) less than 20 or greater than 32
* Bone mineral density (BMD) T-score below -2.0 in lumbar spine or femoral neck

Answer: B