February 2003, Volume 3, Issue 1
Special Points of Interest (click topic)
WHP Clinical Trials
Stress Incontinence
Hormone Replacement Therapy
Sweet Dreams
Sources of Calcium & Vitamin D
Three Generations of IUDs
Contraceptive coverage
Transdermal Patches
Health News?
FDA Approves New Labels
__________________________
Suzanne Trupin, MD, FACOG
2125 South Neil Street, Champaign, IL 61820
PHONE (217)356-3736
FAX (217) 356-5849
www.womenshealthpractice.com
HEALTHY WOMEN NEEDED
Women’s Health Practice is seeking women to join a research study for an investigational vaccine to see if it can help prevent human papilloma virus (HPV)-a virus that can lead to genital warts and cervical cancer in women.
What benefit may you receive?
• Being in this study may not help you. If this study vaccine is effective, you may be protected against the HPV types in the vaccine.
• You will have access to frequent gynecological care, including frequent testing for diseases of the genital tract and frequent Pap testing. Pap testing is the standard of care for detecting disease of the cervix caused by HPV.
Can you refuse to be in the study?
• Your participating in this study is voluntary. You can choose not to take part in the study, or you can quit at any time. Your own doctor will still take care of you. You can ask any questions about this study at any time.
What is HPV?
Human papilloma virus (HPV is the most common sexually transmitted disease in the United States today. There are approximately 100 varieties of this virus, several of which cause genital warts in women and men, and several of which cause genital warts in women and men, and several of which can lead to cervical cancer in women.
Why should I be concerned about HPV?
Both men and women can contract HPV. As a woman:
• There is no cure for HPV.
• You can be infected and not know it.
• If you develop genital warts, they can be treated and even removed, but may grow back.
• HPV has been linked to cervical cancer.
How is HPV detected?
Many women first find out that they have HPV if they are diagnosed with genital warts, or if they have an “abnormal” Pap test during a routine check-up visit with their gynecologists. A Pap test looks for abnormal cells in the cervix.
Remember:
• Many things can cause an abnormal Pap test, including HPV.
• If an HPV infection is left untreated or undiagnosed, there is a risk that it can lead to cervical cancer.
Who’s at risk for HPV?
The average age for contracting this virus is the early 20s. Unfortunately, because HPV can be passed through anal, oral, and vaginal sex and through skin-to-skin contact, condoms do not offer protection against HPV as they do with other sexually transmitted diseases. Also, in many cases, men can be infected with HPV but have no symptoms.
What is the investigational HPV vaccine study?
The HPV vaccine study is a medical research study that seeks to test the safety and efficacy of an investigational vaccine to see if it can help prevent the transmission of HPV. The vaccine does not contain any live virus, so you cannot get HPV from the vaccine.
What are the potential risks for participating in this investigational study?
• Potential side effects from taking the vaccine may include: fever, headache, loss of appetite, nausea, diarrhea, sleeplessness, fatigue, allergic reactions, soreness, tenderness, or swelling at the injections site.
• Possible discomforts associated with study procedures.
• Other adverse effects that are not presently known about the HPV investigational vaccine.
Who can participate in this study?
• You may be eligible to joint the study if you are a healthy woman between the ages of 16 and 23.
What will participants receive for participating in the investigational study?
Women who are eligible and who consent to participate will receive:
• Study-related gynecological care and STD testing during participation.
• Compensation for participation.
Other Clinical Trials Currently Enrolling
• Stress urinary incontinence
• Osteoporosis
• Severe PMS
• Treatment of menopausal symptoms
• Low sex drive after menopause
• Contraception
Informational, walk-in meetings regarding all clinical research studies are normally scheduled on Mondays and Wednesdays at Women’s Health Practice. If interested in any of these studies, to inquire about upcoming informational meetings, or if you want to know more about what participating in a clinical research trial involves, please contact Louise Adam, Clinical Research Coordinator, or Kathleen Snyder, C.A.N.P, at 217-356-3736, extension 118 or 127.
Stress incontinence occurs when the neck of the bladder and the urethra ado not close completely, which is usually due to weakening of the pelvic floor muscles. The symptoms of stress incontinence include:
• Urine leakage with exercise, coughing, laughing, lifting, bending, sneezing, rising from a chair or bed, and/or orgasm.
• The sensation that the bladder is always full or doesn’t empty completely on urination.
• Discomfort during intercourse.
• The urge to urinate occurs more often (particularly at night). Bladder neck support devices, which mechanically restore support to the bladder neck, include:
• Pessaries-silicone or latex devices placed in the vagina.
• Injections-substances can be injected around the urethra to increase bulk.
• Medications-several options available.
Women’s Health Practice is conducting a research study to evaluate the impact on quality of life of an investigational drug compared to placebo in women with symptoms of stress urinary incontinence or SUI. Stress urinary incontinence is the most common form of incontinence in women.
If you are experiencing a sudden leakage when you cough, sneeze, run, bend, lift or laugh-you are not alone. Over 11 million women in the U.S. experience this medical condition and yet there is no medication available. Study volunteers must:
• be 18 years or older
• be able to perform everyday activities
• be willing to use acceptable contraception, if able to have children
• have had symptoms of SUI for at least 3 months
• not currently be taking anti-depressant medication or MAOIs.
There is no cost to participate in the study. If you are eligible, you will receive a study-related clinical evaluation, lab services, and compensation. Contact Women’s Health Practice at 217-356-3736 now to see if you qualify-ask for the research coordinator.
As a volunteer in a WHP clinical trial, you are contributing to the search for new medical treatments and aiding in the development of cures for illness and medical conditions. WHP has been conducting studies for almost twenty years, and we are proud of the advances we have been involved in.
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Health Benefits Associated with the Use of Hormone Replacement Therapy
Indications
• Vasomotor symptoms
• Prevent osteoporosis
Clear Benefits
• HDL/LDL
• Sleep improvement
• Sexuality improvement
Potential Benefits
• Reduction of urogenics
• Reduction of SUI
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Health Risks Associated with the Use of Hormone Replacement Therapy
Clear Side Effects
• Irregular bleeding
• Breast soreness
Potential Side Effects
• Weight gain
• Bloating
• Depression
Clear Risks
• Very small increases in rate of heart disease, stroke, venous thromboembolization, and breast cancer
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Alternatives to HRT
• Selective Estrogen Receptor Modulators (SERMS)
• Herbal and nutritional alternatives
• Bisphosphonates
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Confused about hormone replacement therapy?
Are you a postmenopausal woman with an intact uterus, and between the ages of 40 and 75? You may qualify for a study evaluating an investigational medication to determine if it relieves menopausal symptoms including hot flashes, insomnia, and mood swings.
Study participants will receive the following:
• Study drug
• Study-related clinical evaluations, including mammogram and Pap smear
• Compensation
For more information, please contact the Research Coordinator at Women’s Health Practice (217-356-3736, ext. 118 or 127) or visit our website at www.womenshealthpractice.com.
At WHP we believe it is important to practice healthy living habits daily. A good sleep schedule is necessary for feeling well everyday. Here are some tips to help you sleep well and feel your best.
Principles of Sleep Hygiene
• Do not spend too much time in bed. Limit the time spent in bed to sleeping. If you wake up, get out of bed. Go back to bed only when you are ready to sleep.
• Do not try to force yourself to sleep. The more you try to fall asleep, the more your arousal level will increase, and falling asleep will become more difficult.
• Remove the clock from your bedroom; a ticking clock or luminous clock face can easily prevent you from falling or staying asleep.
• Avoid physical activity late in the evening. Exercise should be completed at least two hours before bed time. But, do exercise regularly as this will make you more physically tired.
• Avoid caffeine, alcohol, and cigarettes after 3 PM.
• Do not eat a heavy meal or a lot of sugar before going to bed.
• Do not drink an excessive amount of liquid before going to bed.
• Go to sleep and wake up at regular hours.
• Do not nap more than 15 minutes during the day.
• Make sure that your sleep environment is as comfortable as possible-consider the factors of temperature, noise, light, humidity, sleep garments, mattress, and covers.
• If you awake early, get up and get active.
If you are having sleep difficulties, your Women’s Health Practice provider can assess your situation and offer treatment recommendations.
– Adapted from Lavie. N Engl J Med. 2001
Sources of Calcium and Vitamin D
Sources of Calcium and Vitamin D
CALCIUM: How much calcium do you need?
• 1,500 mg/day for childern age 9 and older
• 1,000 mg/day for adults aged 19-50
• 1,200 mg/day during pregnancy and lactation
• 1,500 mg/day for estrogen-deficient women over age 50
• 1,500 mg/day for both sexes after age 65.
Sources of calcium include:
• Skim milk (1 cup = 302 mg)
• American cheese (1 oz = 175 mg)
• Yogurt (1 cup = 415 mg)
• Ice cream (1/2 cup = 90 mg)
• Broccoli (1 cup = 136 mg)
• Collards (1 cup = 357 mg)
• Tofu with calcium sulfate (4 oz = 250 to 370 mg)
• Sardines (3 oz = 370 mg)
• Turnip greens (1 cup = 200 mg)
• Bok choy = (1 cup = 160 mg)
To optimize absorption, calcium supplements should be taken with meals and spread out in multiple doses since the body absorbs most efficiently from multiple small doses. For example, five 200-mg calcium tablets, taken at regular intervals over the day, will deliver into the blood almost twice as much calcium as the same total dose of 1,000 mg taken all at once.
Fracture risk reduces 8% for every 1% increase in bone mass. Calcium supplementation provices excellent benefits and has the potential to reduce the incidence of osteoporosis by up to 60%.
If you are unable to get enough calcium in your diet, ask your Women’s Health Practice healthcare provider to recommend a supplement.
VITAMIN D: Vitamin D helps your body absorb caclium. Most multivitamins provide about 400 international units (IU) of Vitamin D. Other ways you can get 400 to 800 IU daily:
• Sunlight: Ten to 15 minutes of sun exposure to bare skin 2 to 3 times a week.
• Fortified milk (1 cup = 100 IU)
• Fortified cereal (1 cup = 40 to 50 IU)
• Egg yolks (1 yolk = 25 IU)
• Shrimp (3 oz = 90 IU)
• Salmon (3 oz - 425 IU)
• Sardines (3 oz - 255 IU)
• Herring (3 oz - 765 IU)
• Cod liver fish oils (1 tablespoon = 1,360 IU)
– Adapted from “What you should know about osteoporosis”, OBG Management, November 2002.
Lippes Loop (1960), TCU380A (1980), GyneFix-mini IUS (2000)
Standard GyneFix IUS
Essure coils in tubal-uterine junction
– Adapted from “Efficacy of a mini version of the framless GyneFix intrauterine system (IUS) with effective copper surface area
of 200 mm2”, Widemeersch D, et al, Contraception 66 (2000) 237-241.
States with Laws Requiring Contraceptive Coverage(1998-2000)
California*
Missouri*
Connecticut*
Nevada*
Delaware*
New Hampshire
Georgia
New Mexico
Hawaii*
North Carolina*
Iowa
Rhode Island
Maine*
Texas
Maryland*
Vermont
Massachussetts
Washington
*State law has a religious exemption (a loophole that permits businesses and insurance companies to refuse contraception coverage based on a religious view held by the employer for insurance company, though not necessarily by the employees or policy holders. These are sometimes known as clauses).
Transdermal (skin) patches are used in managing a wide variety of conditions.
| Indication | Active Ingredient |
| Angina | Nitroglycerine |
| Chronic Pain | Fentanyl |
| Contraception | Norelgestromin/ ethinyl estradiol |
| Hormone Replacement Female | Estradiol; norethindrone acetate/estradiol |
| Hormone Replacement Male | Testosterone |
| Hypertension | Clonidine |
| Motion Sickness | Scopolamine |
| Smoking Cessation | Nicotine |
At Women's Health Practice, transdermal patches are prescribed for contraception, hormone replacement, and smoking cessation. If you desire additional information regarding transdermal therapy, please ask your WHP healthcare provider who will be happy to discuss in further detail.
– Adapted from ARHP's Health & Sexuality; 7(1):7, 2002.
American Cancer Society (ACS) Guidelines for Cervical Cancer Screening.
The ACS has issued new guidelines for Pap smears. Adolescents should be screened no later than 3 years after they first become sexually active or at age 21, whichever comes first. ACS recommends healthy women over the age of 30 who have had three consecutive normal Pap smear results can be screened every 2-3 years. Women at least 70 years of age and have had at least three normal Pap test results in the last 10 years may choose to stop cervical cancer screening. It is still recommended that all age age groups have annual physical examination. Adolescents will need to be tested for sexually transmitted diseases during the first few years of sexual activity and for contraception.
At WHP, our physicians and staff can discuss what guideline is recommended for your individualized health care.
Syphilis Rates Rise.
Primary and second syphilis infection rates rose by 2% between 2000 and 2001; syphilis rates for men rose 15.4% during this time period. This marks the first increase in syphilis rates since 1990.
– Adapted from OB/GYN News; 37(4), December 15, 2002.
FDA Approves New Labels for Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women Following Review of Women’s Health Initiative Data.
FDA’s labeling revisions are part of a series of actions to provide risk management information to women and advice to health care providers who prescribe these estrogen and estrogen with progestin-containing drug products for postmenopausal women. Further information is available online at: http://www.fda.gov/cder/drug/infopage/estrogens_progestins/default.htm