Please select the eligibility criteria that correspond to the clinical trial below.
Title: Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms
Brief Summary: This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.


Options:
A: Inclusion Criteria:

* Menopausal women with intact uterus
* Must be experiencing hot flashes
* No menstrual periods for at least 6 months and no longer than 3 years
* Non-smoker
* Must have intact uterus (no hysterectomy)

Exclusion Criteria:

* Contraindications for hormone replacement therapy
* Diabetes mellitus
* Pregnancy or breast-feeding
* Obese (BMI \>35 excluded)
* History of endometrial hyperplasia/neoplasia/malignancy
* History of breast or reproductive cancer
* History of severe recurrent depression, or severe psychiatric disturbance
* History of stroke/CVA, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart)
* History of abnormal vaginal bleeding of unknown cause
* Untreated or uncontrolled high blood pressure/hypertension
* Use of any medication or supplement containing estrogen, progestin, SERM, St. John's Wort, bisphosphonates, or phytoestrogens
* History of hormone-associated migraines
* History of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders
* Participation in a clinical trial within 30 days
* Abnormal endometrial biopsy or mammogram
* Abnormal transvaginal ultrasound defined as \>7mm thickness
* Vegan
B: Postmenopausal women ages 50 to 79.
C: 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
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: A