Brand Name: Cenestin
Active Ingredient: synthetic conjugated estrogens, A
Indication: Treatment of moderate to severe vasomotor symptoms associated with menopause.
Company Name: Duramed Pharmaceuticals, Inc.
Availability: Prescription only
On March 24, 1999 the FDA granted approval to Duramed Pharmaceuticals, Inc. to market CenestinTM (synthetic conjugated estrogens, A) Tablets, a new plant-derived synthetic conjugated estrogens product for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
Cenestin is a blend of nine synthetic conjugated estrogens derived from plant sources that provides an alternative to animal-derived estrogens. Currently, Cenestin is approved only for short-term use and no long-term studies, such as in the prevention of osteoporosis, have been completed.
The average age of American women at menopause is 51.
According to the American College of Obstetrics and Gynecologists, the first wave of “Baby Boomer” women (born 1945 – 1960) are now entering menopause and another 20 million will reach menopause in the next decade.
Currently, more than 40 million women in the U.S. are over 50 and eligible to take either ERT (estrogen only) or HRT (estrogen with a progestin).
How It Works
As estrogen levels decrease during menopause, some women experience unpleasant symptoms such as hot flashes or hot flushes. The use of an estrogen replacement, such as Cenestin, allows the body to adjust to lower estrogen levels, thereby reducing these symptoms. The majority of women with these symptoms do not need estrogen replacement for longer than six months.
Cenestin: Clinical Study Results
The effectiveness of Cenestin in treating vasomotor symptoms was evaluated in a randomized, placebo-controlled study involving 120 menopausal women. The 0.625 mg daily dose of Cenestin was titrated up or down as required. After 12 weeks’ treatment, 77% of patients required a dose of 1.25 mg per day. Compared to placebo, Cenestin reduced moderate-to-severe vasomotor symptoms at all time points.
What The Patient Should Know
Like all estrogen drug products, Cenestin should not be used in women with known or suspected pregnancy, breast cancer, or estrogen- dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders.
The risk of developing cancer of the uterus increases with the dosage and duration of estrogen replacement therapy. Therefore it is important to ascertain that the lowest effective dose is being used and for no longer than is necessary. Using progesterone therapy together with estrogen therapy may reduce the risk of uterine cancer related to estrogen use.
An increased risk of breast cancer in patients who have used estrogens has not been shown in most studies. However, some studies have shown an increased rate in women who used estrogens for long periods or at high doses for shorter periods. A regular breast examination by a health professional and monthly self-examination is recommended. Yearly mammography is recommended beginning at age 50.
Estrogen use can increase the coagulability of blood, possibly resulting in stroke, myocardial infarction, or pulmonary embolism.
Gallbladder disease needing surgery is more likely to develop in women who use estrogens after menopause compared to those who do not use estrogens.
Patients should be informed that nausea and vomiting, breast tenderness or enlargement, enlargement of benign tumors of the uterus (fibroids), retention of excess fluid, or spotty darkening of the skin can occur with the use of estrogens.