Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III, Multicenter, Double-Blind Study of the Safety and Efficacy of Bio-E-Gel (Topical Estradiol Gel) Versus Placebo for Treatment of Vasomotor Symptoms and Vulvovaginal Atrophy in Postmenopausal Females
Brief Summary: The purpose of this study is to determine the efficacy and safety of a topical estradiol gel for the treatment of hot flushes in postmenopausal women.


Options:
A: Inclusion Criteria:

* Post menopausal women,
* Ages 35 or older,
* Frequent moderate to severe hot flushes,
* Qualifying general medical health

Exclusion Criteria:

* Disqualifying gynecological disorders,
* Disqualifying dermatological disorders,
* Disqualifying concurrent conditions
B: Inclusion Criteria:

* Menopause
* Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)

Exclusion Criteria:

* Hormonal treatment
* Contraindication to estrogen/progestogen therapy
C: Inclusion Criteria:

1. Women 40-60 years old;
2. Postmenopausal status, as documented by absence of periods for ≥ 1 year or amenorrhea for ≥ 6 months along with FSH ≥ 40 IU/L;
3. Surgical menopause;
4. History of a normal mammogram within the last 11 months;
5. Normal screening labs (within 20% of upper limit of lab normal);
6. Able to understand and sign informed consent; and
7. Able and willing to be in a monitored CRU setting and provide blood samples as requested.

Exclusion Criteria:

1. Contraindications to the use of hormones because of personal history of coronary artery disease, stroke, breast cancer, DVT/PE, active liver or gall bladder disease, hormone dependent migraine headaches, endometrial, ovarian or other hormone dependent cancers;
2. Medical conditions increasing the risk of complications from hormone replacement such as uncontrolled hypertension (\>160/100 mmHg), smoking, diabetes and lupus;
3. Current use of estrogen, progesterone or testosterone;Depending on the drug, it could be 7 days to 6 months.
4. Current use of isoflavone containing products;
5. Current use of protein binding medications like rifampin, warfarin, antiepileptic drugs (effect on estrogen bioavailability);
6. Family history of premenopausal breast cancer in a first degree relative, two or more premenopausal breast cancers in second degree relatives, male breast cancer, ovarian cancer in two or more relatives and; and
7. Women with alcohol or substance abuse or dementia (compliance issues).
8. Women who are more than ten years from their last menstrual period (unfavorable risk : benefit ratio)
9. Women with peanut allergy (Prometrium has peanut oil)
10. Women who are found to have premenopausal estrogen levels, as confirmed by a baseline Estradiol level of \>35 pg/ml and vaginal ultrasound suggesting ovarian activity.
D: Inclusion Criteria:

* Postmenopausal women
* serum estradiol level less than or equal to 20 pg per mL
* serum FSH greater than 40 mIU per mL

Exclusion Criteria:

* Pathological cancer findings on screening
* abnormal endometrium
* serious hepatic, renal or cardiac disease

Answer: D