Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2000-07-11
2004-02-17
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C425S451000, C425S464000
Reexamination Certificate
active
06692763
ABSTRACT:
BACKGROUND OF THE INVENTION
Endogenous estrogens fall dramatically after natural or surgical menopause, and this decline results in a marked increase in bone loss and subsequent fractures. Endogenous estrogens are clearly important for the maintenance of skeletal health in younger women. However, the importance of endogenous estrogens in older women is less certain.
It has been previously shown that endogenous estrone levels in women over age 65 were not associated with subsequent hip or vertebral fractures. S. R. Cummings, et al.,
J. Bone Min. Res.
10 (Suppl I):S174 (1995). However, estradiol is a more potent estrogen that estrone, and studies of its relationship to fractures have been inconclusive. Serum estradiol levels in premenopausal women average over 100 pg/ml. Serum estradiol levels in postmenopausal women not being treated with hormone replacement therapy fall below 20 pg/ml and as many as 30-50 percent of postmenopausal women have serum estradiol levels which are undetectable by conventional, sensitive assay methods (i.e., less than 5 pg/ml). Conventional treatment for postmenopausal women includes estrogen replacement therapy in doses sufficient to maintain serum estradiol levels above 40-60 pg/ml.
Conventional hormone replacement therapy has proven useful for treating physical conditions resulting from postmenopausal estrogen decline, including reducing the loss of, or even increasing bone density; and decreasing the risk of bone fracture. However, studies have indicated that hormone replacement therapy may be linked to increased risk of breast and endometrial cancers, as well as blood clotting and bleeding from the uterus. Accordingly, there remains a need in the art for methods of treating the physical conditions which result from postmenopausal estrogen decline or deficiency. There also remains a need in the art for treating such physical conditions while reducing the side effects of hormone replacement therapy.
SUMMARY OF THE INVENTION
As a first aspect, the present invention provides a method for treating physical conditions resulting from estrogen decline in a postmenopausal subject. The method comprises administering to the subject, an amount of estrogen which is effective to produce a serum estradiol level of between about 5 pg/ml and about 15 pg/ml.
As a second aspect, the present invention provides a method for reducing the risk of osteoporotic bone fractures in a subject afflicted with or susceptible to postmenopausal osteoporosis. The method comprises administering to the subject, an amount of estrogen which is effective to produce a serum estradiol level of between about 5 pg/ml and about 15 pg/ml.
As a third aspect, the present invention provides a kit for use by a consumer afflicted with or susceptible to physical conditions resulting from postmenopausal estrogen decline. The kit comprises a) a transdermal patch capable of transdermally administering less than about 20 &mgr;g of estrogen per day; and b) instructions describing a method of using the transdermal patch to reduce the risk of bone fracture in the consumer.
As a fourth aspect, the present invention provides another method for treating physical conditions resulting from postmenopausal estrogen decline in a postmenopausal subject. The method includes administering less than about 20 &mgr;g of estrogen per day in the absence of exogenous progestin.
As a fifth aspect, the present invention provides another method for reducing the risk of osteoporotic bone fractures in a subject afflicted with or susceptible to osteoporosis. The method includes administering less than about 20 &mgr;g of estrogen per day in the absence of exogenous progestin.
These and other aspects of the present invention are described further in the drawings, description of the preferred embodiment and examples of the invention which follow.
REFERENCES:
patent: 3797494 (1974-03-01), Zaffaroni
patent: 4031894 (1977-06-01), Urquhart et al.
patent: 4096254 (1978-06-01), Benson et al.
patent: 4460372 (1984-07-01), Campbell et al.
patent: 4573996 (1986-03-01), Kwiatek et al.
patent: 4624665 (1986-11-01), Nuwayser
patent: 4722941 (1988-02-01), Eckert et al.
patent: 5188835 (1993-02-01), Lindskog et al.
patent: 5223261 (1993-06-01), Nelson et al.
patent: 5460820 (1995-10-01), Ebert et al.
patent: 5891868 (1999-04-01), Cummings et al.
patent: 0 569 338 (1993-05-01), None
patent: 569 338 (1993-11-01), None
Balfour et al., “Transdermal Estradiol . . . ,”Drugs, 40(4):561-582 (1990).
Ettinger et al., “Long-Term Estrogen Replacement Therapy Prevents Bone Loss and Fractures,”Ann. Int. Med., 102:319-324 (1985).
Ettinger et al., “Prostmenopausal Bone Loss is Prevented by Treatment with Low-Dosage Estrogen with Calcium,”Ann. Int. Med., 106:40-45 (1987).
Ettinger et al., “Low-dosage micronized 17&bgr;-estradiol prevents bone loss in postmenopausal women,”Am. J. Obst. Gyn., 166(2):479-488 (1992).
Evans et al., “Low and conventional dose transdermal oestradiol are equally effective at preventing bone loss in spine and femur at all postmenopausal ages,”Clin. Endo., 44:79-84 (1996).
Hillard et al., “Long-Term Effects of Transdermal and Oral Hormone Replacement Therapy on Postmenopausal Bone Loss,”Osteoporosis Int., 4:341-348 (1994).
Horsman et al., “The Effect of Estrogen Dose on Post-menopausal Bone Loss,”N. Eng. J. Med., 309(23):1405-1407 (1983).
Lindsay et al., “The Minimum Effective Dose of Estrogen for Prevention of Postmenopausal Bone Loss,”Obst. Gyn., 63(6):759-763 (1984).
Naessen et al., “Bone Loss in elderly women prevented by ultralow doses of parental 17&bgr;-estradiol,”Am. J. Obst. Gyn., 177(1):115-119 (1997).
Stevenson et al., “Effects of transdermal versus oral hormone replacement therapy on bone density in spine and proximal femur in postmenopausal women,”The Lancet, 336:265-269 (1990).
Tepper et al., “Estrogen Replacement in Postmenopausal Women: Are We Currently Overdosing Our Patients,”Gyn. Obst. Invest., 38:113-116 (1994).
Cummings Steven R.
Ellman Herman
Ettinger Bruce
Ghali Isis
Page Thurman K.
The Regents of the University of California
Townsend and Townsend / and Crew LLP
LandOfFree
Methods for treating postmenopausal women using ultra-low... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods for treating postmenopausal women using ultra-low..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods for treating postmenopausal women using ultra-low... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3332986