The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

October 22, 1999

Specific Treatments:

Treatment of vasomotor symptoms assoc. w/menopause; vulvar, vaginal atrophy; prevention of osteoporosis

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General Information

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 Results

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.

Side Effects

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.

Additional Information

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