Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Brief Summary: The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.


Options:
A: Inclusion Criteria

* Females aged 45-70 years
* 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy)
* At least 1 vaginal symptom (inside or outside the vagina) reported from the following list, experienced in the past 30 days which is moderate or severe:

  * Dryness at least once a week
  * Itching at least once a week
  * Irritation at least once a week
  * Soreness/Pain at least once a week
  * Pain associated with sexual activity at least once
* Signed informed consent

Exclusion Criteria

* Current unexplained abnormal genital bleeding (or any unevaluated bleeding since menopause)
* Currently pregnant, attempting pregnancy or breast feeding
* Current acute vaginal infection (as indicated by wet mount at V1)
* Pelvic or vaginal surgery in prior 60 days
* Antibiotic use in the past 30 days
* Women under age 55 with endometrial ablation
* Women under age 55 with hysterectomy and at least one ovary
* Current cancer treatment (exception basal or squamous skin cell cancers)
* Current or past thromboembolic disease (pulmonary embolus or deep vein thrombosis, not including thrombophlebitis), myocardial infarction or stroke
* Current severe liver disease
* Current or past breast or endometrial cancer or pre-cancer
* Blood clotting disorder (e.g., Factor V Leiden, prothrombin mutation, protein C, protein or antithrombin deficiency)
* Porphyria
* Current or past lichen sclerosus or lichen planus
* History of adverse reaction to vaginal estrogen or Replens
* Use of any systemic reproductive hormones (hormonal contraception, postmenopausal hormone therapies, SERMS) in the past 2 months
* Use of hormonal contraception in the past year
* Use of any type of vaginal estrogen product (however interested women will be allowed to join the study if they abstain from use during the month preceding enrollment)
* Use of any type of vaginal moisturizer, douche, vaginal prebiotic or probiotic, or soap in the vagina in the past month (however interested women will be allowed to join the study if they abstain from use during the month preceding enrollment)
* Unwilling to abstain from use of any non-study vaginal moisturizer, vaginal estrogen, douche, or soap in the vagina throughout the trial
* Unable to follow instructions, complete questionnaires, or physically unable to place product in the vagina
* Current participation in another drug trial or intervention study
* Chronic vulvo-vaginal symptoms in the 5 years before menopause (defined as a vaginal or vulvar condition requiring more than 4 visits to a health care provider in a given year)
B: Inclusion Criteria:

* Generally healthy, postmenopausal women aged 40 - 75 years inclusive
* Intact uterus
* Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening

Exclusion Criteria:

* A history or active presence of thrombophlebitis, thrombosis or thromboembolic disorders
* A history or active presence of cerebrovascular accident, stroke, or transient ischemic attack
* A history or active presence of malignancy, or treatment for malignancy, within the previous 10 years

Additional criteria applies.
C: 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
D: Inclusion Criteria:

* Postmenopausal women whose last menstruation was at least two years previously

Answer: B