Hormone preparation and method
First Claim
1. A contraceptive preparation for administration to a female of childbearing capability comprising repeating cycles of a contraceptive regimen, each cycle having a series of twenty to thirty-five consecutive daily unit doses arranged in alternating estrogen dominant phases and progestin dominant phases, each phase consisting of from two to four consecutive daily unit doses, wherein the daily unit doses of said estrogen dominant phases contain i) an amount of a substance exhibiting estrogen activity or ii) an amount of a substance exhibiting estrogen activity and an amount of a substance exhibiting progestin activity, and the daily unit doses of said progestin dominant phases contain an amount of a substance exhibiting estrogen activity and an amount of a substance exhibiting progestin activity;
- wherein the amount of said substance exhibiting progestin activity is alternately increased in the progestin dominant phases to provide daily unit doses exhibiting progestin dominant activity and decreased in the estrogen dominant phases to provide daily unit doses exhibiting estrogen dominant activity, and wherein the amount of substance exhibiting estrogen activity per unit dose exhibits an estrogen activity equivalent to from about 0.02 to about 0.05 mg of 17α
-ethinyl estradiol and the amount of substance exhibiting progestin activity per unit dose ranges from 0 to an amount which exhibits a progestin activity equivalent to about 1 mg of norethindrone.
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Accused Products
Abstract
This invention is concerned with a contraceptive formulation and a method of contraception which employs a combination of estrogen and progestin and wherein a short period of relatively dominant estrogenic activity alternates with a short period of relatively dominant progestagenic activity. The invention also concerns a hormonal replacement formulation and method for use in menopausal or castrate women which employs a similar combination of estrogen and progestin.
103 Citations
22 Claims
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1. A contraceptive preparation for administration to a female of childbearing capability comprising repeating cycles of a contraceptive regimen, each cycle having a series of twenty to thirty-five consecutive daily unit doses arranged in alternating estrogen dominant phases and progestin dominant phases, each phase consisting of from two to four consecutive daily unit doses, wherein the daily unit doses of said estrogen dominant phases contain i) an amount of a substance exhibiting estrogen activity or ii) an amount of a substance exhibiting estrogen activity and an amount of a substance exhibiting progestin activity, and the daily unit doses of said progestin dominant phases contain an amount of a substance exhibiting estrogen activity and an amount of a substance exhibiting progestin activity;
- wherein the amount of said substance exhibiting progestin activity is alternately increased in the progestin dominant phases to provide daily unit doses exhibiting progestin dominant activity and decreased in the estrogen dominant phases to provide daily unit doses exhibiting estrogen dominant activity, and wherein the amount of substance exhibiting estrogen activity per unit dose exhibits an estrogen activity equivalent to from about 0.02 to about 0.05 mg of 17α
-ethinyl estradiol and the amount of substance exhibiting progestin activity per unit dose ranges from 0 to an amount which exhibits a progestin activity equivalent to about 1 mg of norethindrone. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- wherein the amount of said substance exhibiting progestin activity is alternately increased in the progestin dominant phases to provide daily unit doses exhibiting progestin dominant activity and decreased in the estrogen dominant phases to provide daily unit doses exhibiting estrogen dominant activity, and wherein the amount of substance exhibiting estrogen activity per unit dose exhibits an estrogen activity equivalent to from about 0.02 to about 0.05 mg of 17α
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13. A contraceptive package containing at least one cycle of a contraceptive regimen for administration to a female of childbearing capability wherein each cycle comprises a series of twenty to thirty-five consecutive daily unit dosages, arranged in a fixed sequence corresponding to an intended order of administration consisting of alternating estrogen dominant phases and progestin dominant phases, each phase consisting of from two to four consecutive daily unit doses, wherein the daily unit doses of said estrogen dominant phases contain i) an amount of a substance exhibiting estrogen activity or ii) an amount of a substance exhibiting estrogen activity and an amount of a substance exhibiting progestin activity, and the daily unit doses of said progestin dominant phases contain an amount of a substance exhibiting estrogen activity and an amount of a substance exhibiting progestin activity;
- wherein the amount of said substance exhibiting progestin activity is alternately increased in the progestin dominant phases to provide daily unit doses exhibiting progestin dominant activity and decreased in the estrogen dominant phases to provide daily unit doses exhibiting estrogen dominant activity, and wherein the amount of substance exhibiting estrogen activity per unit dose exhibits an estrogen activity equivalent to from about 0.02 to about 0.05 mg of 17α
-ethinyl estradiol and the amount of substance exhibiting progestin activity per unit dose ranges from 0 to an amount which exhibits a progestin activity equivalent to about 1 mg of norethindrone. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22)
- wherein the amount of said substance exhibiting progestin activity is alternately increased in the progestin dominant phases to provide daily unit doses exhibiting progestin dominant activity and decreased in the estrogen dominant phases to provide daily unit doses exhibiting estrogen dominant activity, and wherein the amount of substance exhibiting estrogen activity per unit dose exhibits an estrogen activity equivalent to from about 0.02 to about 0.05 mg of 17α
Specification