Ensayos clínicos

Inclusion Criteria:

Potentially eligible subjects must:

1. Currently be between 45-60 years of age;
2. Have bothersome hot flashes (defined by their occurrence of ≥ 28 times per week and of sufficient severity to prompt the patient to seek therapeutic intervention).
3. Hot flashes must be present for >30 days prior to study entry;
4. Currently have a body weight of greater than 50 kg (110 pounds);
5. Currently have a BMI 27–29.9 kg/m2 with a weight related co-morbidity per package label such as hypertension, dyslipidemia, OSA etc;
6. Able to participate fully in all aspects of the study;
7. Have understood and signed study informed consent.

Exclusion Criteria:

Subjects will be excluded if they:

1. Have used weight loss medications or participated in a weight loss program within the past 30 days;
2. Currently taking supplements known to affect weight, such as garcinia cambrogia;
3. Have had weight fluctuations of 20 pounds or more in the past 6 months (self-report);
4. Have a known active eating disorder;
5. Have a known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression);
6. Have used an investigational drug within 30 days of study enrollment;
7. Are currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception; Acceptable forms of contraception include:
   1. Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
   2. Copper IUD
   3. Hysterectomy and/or bilateral salpingo-oophorectomy
   4. Tubal ligation
   5. Abstinence (no sex)
8. Any current (past 4 weeks) or planned use of
   1. Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets). Low dose vaginal estrogen is acceptable
   2. Antineoplastic chemotherapy (anti-HER2 agents allowed)
   3. Androgens
   4. Progestogens
   5. Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period
   6. Gabapentin
   7. Clonidine
   8. Agents with known anticholinergic activity
9. have a history of any major cardiovascular events including heart valve disease, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease;
10. have current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions;
11. have current (in the past 30 days) clinically significant acute or chronic progressive or unstable/uncontrolled neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or endocrine disorders..
12. have had surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. within 12 months prior to enrollment.
13. any medical condition known to affect weight levels and/or to cause bloating or swelling;
14. any concurrent use of serotonergic drugs (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), triptans, bupropion, dextromethorphan, St. John’s Wort) will be assessed by the physician on a case by case basis;
15. current active cancer or currently receiving treatment for cancer; or are within 1 year of cancer remission;
16. have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence