ORTHO-PREFEST is a single-tablet prescription hormone replacement therapy (HRT) indicated in women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause, treatment of vulvar and vaginal atrophy, and prevention of osteoporosis.
Clinical trials tested post-menopausal women and found that ORTHO-PREFEST was safe and effective in reducing hot-flashes and providing relief from vaginal atrophy.
The most common side effects in clinical trials over a one-year period were headache and breast pain. These effects were rarely serious enough to cause women to discontinue treatment. Other side-effects experienced by patients during trials included back pain, fatigue, flu-like symptoms, abdominal pain, nausea, arthralgias (joint pain), dysmenorrhea (painful menstruation), vaginal bleeding, vaginitis, pharyngitis (inflammation of the throat), sinusitis and URIs (upper respiratory infections).
Estrogens have been associated with increased risks of serious
side-effects including thromboembolic disorders, cardiovascular
disease, and endometrial carcinoma in post-menopausal women.
Do not take this drug (or any estrogens) if you have a known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia. Also, do not take estrogens if you have undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders.
Women should consult their doctor before beginning hormone replacement therapy.
Upon launch, the ORTHO-PREFEST will be co-promoted with Women
First HealthCare, a specialty health care company dedicated to
improving the health of midlife women.
For more information, please contact Nancy Casey of Women First HealthCare, Inc., 858-509-3814, or visit the Women First Healthcare, Inc. web site