Please select the eligibility criteria that correspond to the clinical trial below.
Title: Double Blind, Placebo-controlled Study of Efficacy, Safety and Tolerance of Raloxifene as an Adjuvant Treatment for Negative Symptoms of Schizophrenia in Postmenopausal Women
Brief Summary: Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal women.

This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant treatment to antipsychotic treatment. Treatment period of 12 weeks.

The primary result obtained is that women treated with 60 mg of raloxifene compared to those treated with a placebo show greater improvement in psychotic symptoms. The investigators also found improved response in some aspects of social functioning and neuropsychological functioning.


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:

* Diagnosis of schizophrenia (DSM-IV criteria)
* Postmenopausal patients. Postmenopause is defined as after a period of one year of spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) level \> 20IU/L.
* Stable doses of their current antipsychotic medication for at least a month prior to study initiation.
* Presence of significant negative symptoms (defined as one or more negative symptom score greater than 4 in the PANSS scale) (Kay 1987)
* Patients have to give written informed consent to participate in the study.

Exclusion Criteria:

* Patients with a substance abuse/dependence diagnosis in the previous six months.
* Mental retardation.
* Endocrine abnormalities, acute or chronic liver disease, impaired kidney function.
* History of thromboembolism, breast cancer, abnormal uterine bleeding, history of cerebrovascular accident.
* Patients taking hormone replacement therapy.
* Patients taking mood stabilizer medication that cannot be discontinued.
C: Inclusion Criteria:

* Subject is postmenopausal.
* Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

Exclusion Criteria:

* Subject has clinically significant abnormal findings in the physical examination.
* Subject has a body mass index (BMI) equal to or greater than 38 kg/m\^2
* Subject has uncontrolled hypertension.
* Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy.
* Subject has uterine/vaginal bleeding of unknown origin.
* Subject has a vaginal infection requiring medication (may be treated and be eligible for study).
D: 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

Answer: B