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 Methods and formulations for use in treating oophorectomized women

Details
Inventors: Pike, Malcolm C.; Spicer, Darcy V.;
Assignee: University of Southern California (Los Angeles, CA)
Primary Examiner: Page; Thurman K.
Assistant Examiner: Azpuru; Carlos
Attorney, Agent or Firm: Robbins, Berliner & Carson

Compositions and methods which are effective to prevent symptoms of loss of ovarian function (e.g., in oophorectomized women) over a period of time are described, consisting essentially of an effective amount of an estrogenic composition and an effective amount of an androgenic composition. The levels of estrogens and androgens employed are sufficient to reduce bone mineral density loss and minimize other side effects observed after oophorectomy, and at such low doses as to minimize any adverse impact on the patient's long-term prognosis or (in the case of testosterone) result in additional side effects.

DETAILED DESCRIPTION OF THE INVENTION Pursuant to the present invention, the regimen comprises a slow-release (or depot) formulation which is effective for an extended period of time.
Depending on the composition and mode of administration, the inventive formulation may be effective for as short a period as 3 days to as long as six months or more; extended-use formulations may be effective for as long as five years or more.
It is presently preferred that the formulation be effective over about a three or four month period.
Many of the side effects of oophorectomy reflect the hypoestrogenic state and can thus be prevented in accordance with the present invention by add-back estrogen therapy.
Accordingly, in accordance with the present invention an effective amount of an estrogenic composition is administered to prevent symptoms and signs of estrogen deficiency.
As the add-back estrogen, a single-component natural or synthetic estrogen composition or a combination of such compositions can be used to maintain a constant systemic level.
A substantial body of information exists concerning the effects of hormone replacement therapy after a natural or surgical menopause.
Although more is known about the effects of conjugated equine estrogens (CEE) as estrogen replacement therapy (ERT) than any other agent, it is presently preferred that a single-component or two-component composition be employed.
As used herein, estrogenic compositions refer to both the natural and the synthetic materials.
These materials are well known in the art.
Natural and synthetic estrogenic compositions which can be used according to the invention described herein include natural estrogenic hormones and congeners, including, but not limited to, estradiol, estradiol benzoate, estradiol cypionate, estradiol valerate, estrone, diethylstilbestrol, piperazine estrone sulfate, ethinyl estradiol, mestranol, polyestradiol phosphate, estriol, estriol hemisuccinate, quinestrol, estropipate, pinestrol and estrone potassium sulfate



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