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Clinical Trials Resource Center

FDA Approved Drugs » 1999
Medical Areas: Endocrinology | Musculoskeletal | Obstetrics/Gynecology (Women’s Health) | Family Medicine

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Femhrt Tablets

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

Company: Parke-Davis
Approval Status: October 15, 1999
Treatment Area: For the treatment of moderate to severe vasomotor symptoms associated with menopause, and the prevention of osteoporosis

General Information

femhrt 1/5 is a combination of an estrogen hormone, ethinyl estradiol, and a progestin hormone, norethindrone acetate. It should be used to relieve symptoms associated with menopause, and also for the prevention of osteoporosis.
For the treatment of menopausal symptoms:
Femhrt 1/5 will replace the dropping levels of estrogen in women experiencing menopause. The treatment will reduce moderate to severe symptoms, such as hot flashes or feelings of warmth in the face, neck, and chest. Femhrt should be taken to relieve these symptoms only as long as the symptoms persist, especially if patient is taking hormones for other reasons.
For the prevention of osteoporosisFemhrt is most effective in the prevention of osteoporosis (the thinning of the bones) when taken as part of an osteoporosis-prevention regimen, including exercise and calcium supplements.

Clinical Results

Although the full clinical trial profile was not available by the FDA, a study on 18 post-menopausal women tested the effects of the femhrt hormone replacement therapy in an altered dose (1mg NA/10mcg EE). Results indicated that the hormones were rapidly absorbed, with the highest plasma concentrations of norethindrone acetate and ethinyl estradiol occurring at 1 to 2 hours postdose. The 1/10 dose were generally found to be proportional to the marketed 1/5 dose.

Side Effects

Taking estrogen-containing drugs increases the risk of cancer of the uterus, and may, under some conditions, increase the risk of breast cancer. Although the risk is not as severe when progestins accompany the estrogen (as in the femhrt 1/5 combination), patients taking femhrt should get regular check-ups and perform regular breast self-examinations. Gallbladder disease, blood clotting, and vaginal bleeding are all also possible serious side-effects to the hormone treatment.

Additional side-effects reported by women taking the estrogen hormone include:
nausea and vomiting, breast tenderness or enlargement, headache, retention of extra fluid (edema), runny nose, abdominal pain, enlargement of non-cancerous tumors (fibroids) of the uterus, skin rashes and other skin abnormalities.

Mechanism of Action

After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by peripheral tissues. Thus, estrone and the sulphate conjugated form, estrone sulphate, are the most abundant circulating estrogens in postmenopausal women. The pharmacologic effects of ethinyl estradiol are similar to those of endognous estrogens. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) through a negative feedback mechanism. Estrogen replacement therapy acts to reduce the elevated levels of these hormones seen in postmenopausal women.

Progestin compounds enhance cellular differentiation and generally oppose the actions of estrogens by decreasing estrogen receptor levels, increasing local metabolism of estrogens to less active metabolites, or inducing gene products that blunt cellular responses to estrogen. (FDA Label)

Additional Information

Visit the following web sites for more information about the benefits and risks of hormone replacement therapy (HRT) and related subjects:
www.pslgroup.com/MENOPAUSE.HTM


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