Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause
Brief Summary: This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.


Options:
A: Inclusion Criteria:

* Postmenopausal women between ages 48-55
* Minimum of 6 months and maximum of 36 months from last menstrual period
* Postmenopausal status of these women will be confirmed by level of FSH that should exceed 30 U/l
* Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas eighty comparators must be symptomless

Exclusion Criteria:

* smoking
* hysterectomy
* dyslipidemia
* overt hypertension (blood pressure \> 140/90)
* diabetes
* any regular medication
* HT in the previous 3 months
* body mass index over 27
B: Inclusion Criteria:

* Generally healthy
* Postmenopausal
* Hysterectomized or non-hysterectomized
* Moderate or severe vaginal dryness and soreness

Exclusion Criteria:

* Known, suspected, or past history of breast cancer
* Known, suspected, or past history of hormone-dependent tumor
* Genital bleeding of unknown etiology
* Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
* Vaginal infection
* Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
* Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
* History of treatment with diethylstilbestrol
C: Inclusion Criteria:

* menses absent for at least 6 months and no more than 36 months
* good general health
* plasma FSH level greater than or equal to 35 mIU/ml
* estradiol levels \< 40 pg/ml
* normal mammogram within 1 year of randomization

Exclusion Criteria:

* use of hormone replacement or supplement within 3 months of randomization
* endometrial thickness \>5 mm by vaginal ultrasound
* in utero exposure to diethylstilbestrol (DES)
* current smoking \> 10 cigarettes/day
* obesity-body mass index \> 35
* history of clinical cardiovascular disease
* history of cerebrovascular disease
* history of thromboembolic disease
* coronary calcium score ≥ 50 units
* dyslipidemia-LDL cholesterol \>190 mg/dl
* hypertriglyceridemia-triglycerides \>400 mg/dl
* lipid lowering medication (statin, fibrate,or \> 500 mg/day of niacin)
* nut allergy (Prometrium includes peanut oil)
* uncontrolled hypertension-systolic BP \>150 and/or diastolic BP \> 95
* hysterectomy
* history of, or prevalent, chronic diseases including any cancer (other than basal cell skin cancers), renal failure, cirrhosis, diabetes mellitus, and endocrinopathies other than adequately treated thyroid disease
* known HIV infection and/or medications for HIV infection
* results of any safety laboratory test chemistries, (TSH, CBC, U/A) more than 20% abnormal
D: Inclusion Criteria:

* Menopausal with absence of menstruation for at least 12 months
* Presence of vaginal atrophy symptoms \[subjective assessment of vaginal dryness \>7cm on VAS)
* Prolapse stage \< II, according to the pelvic organ prolapse quantification (POP-Q) system\[31\]
* No pelvic surgery within 6 months prior to treatment (vulva biopsy may be included after 2 weeks)
* Understanding and acceptance of the obligation to return for all scheduled follow-up visits

Exclusion Criteria:

* Personal history of vulvovaginal condyloma,,vaginal intraepithelial neoplasia (VAIN), vaginal carcinoma, lichen sclerosis, lichen planus, history of vaginal radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation
* Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. bacterial; vaginosis, herpes genitalis, candida).
* Personal history of Scleroderma
* Any serious disease, or chronic condition, that could interfere with the study compliance
* Previously undergone reconstructive pelvic surgery within the past 6 months
* Previously undergone reconstructive pelvic surgery with transvaginal mesh kits and sacrocolpopexy with synthetic mesh for prolapse, excluding synthetic slings (unless current untreated exposure or extrusion)
* Have used vaginal estrogen cream, ring or tablet within 1 month prior to entering the study
* Vaginal moisturizers, lubricants or homeopathic preparations within 2 weeks of therapy
* Personal history of thrombophlebitis
* Personal history of heart failure or myocardial infarction within 12 months of procedure
* Use or anticipated use of antiplatelet therapy, anticoagulants, thrombolytics, vitamin E or nonsteroidal anti-inflammatory drugs within 2 weeks pre-treatment
* Taking medications that are photosensitive
* Contraindication to Vaginal Estrogen Therapy
* Unwilling to Take Vaginal Estrogen
* Inability to give informed consent

Answer: D