Claims for Patent: 8,153,616

Summary for Patent: 8,153,616

Title:	Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same
Abstract:	The multiphase combination preparation for oral therapy of dysfunctional uterine bleeding and for oral contraception contains a first phase consisting of 2 daily dosage units, each containing 3 mg of estradiol valerate or <3 mg of estradiol; a second phase consisting of a first group of 5 daily dosage units, each consisting of a combination of 2 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol, and a second group consisting of 17 daily dosage units, each consisting of a combination of 3 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol; a third phase consisting of 2 daily dosage units, each containing 1 mg of estradiol valerate or <1 mg of estradiol; and another phase consisting of 2 daily dosage units of a pharmaceutically harmless placebos.
Inventor(s):	Zeun; Susan (Berlin, DE), Boudes; Pol (Hackettstown, NJ), Secci; Angelo (Parsipanny, NJ), Nedrikat; Jan (Chianti Kirkland, CA), Zimmermann; Holger (Falkensee, DE)
Assignee:	Bayer Pharma Aktiengesellschaft (Berlin, DE)
Application Number:	11/609,705
Patent Claims:	1. A method of treating dysfunctional uterine bleeding and of oral contraception, comprising orally administering to a woman in need of treatment for dysfunctional uterine bleeding and desiring oral contraception, over at least one treatment cycle of 28 days, one dosage unit comprising 3 mg of estradiol valerate daily for 2 days, then one dosage unit comprising 2 mg of estradiol valerate and 2 mg of dienogest daily for 5 days, then one dosage unit comprising 2 mg of estradiol valerate and 3 mg of dienogest daily for 17 days, then one dosage unit comprising 1 mg of estradiol valerate daily for 2 days, and then one dosage unit comprising a pharmaceutically acceptable placebo daily for 2 days. 2. The method of claim 1, comprising six of said treatment cycles of 28 days. 3. A method of treating dysfunctional uterine bleeding and of oral contraception, comprising orally administering to a woman in need of treatment for dysfunctional uterine bleeding and desiring oral contraception, over at least one treatment cycle of 28 days, a first phase of 2 daily oral dosage units, each comprising 3 mg of estradiol valerate, a second phase of 2 groups of daily oral dosage units, a first group comprising 5 daily oral dosage units, each of which comprises 2 mg of estradiol valerate and 2 mg of dienogest, and a second group comprising 17 daily oral dosage units, each of which comprises 2, mg of estradiol valerate and valerate and 3 mg of dienogest; a third phase of 2 daily oral dosage units, each comprising 1 mg of estradiol valerate, and a fourth phase of 2 daily oral dosage units, each comprising a pharmaceutically acceptable placebo. 4. The method of claim 3, comprising six of said treatment cycles of 28 days. 5. A method of treating dysfunctional uterine bleeding, comprising orally administering to a woman in need of treatment for dysfunctional uterine bleeding, over at least one treatment cycle of 28 days, a first phase of 2 daily oral dosage units, each comprising 3 mg of estradiol valerate, a second phase of 2 groups of daily oral dosage units, a first group comprising 5 daily oral dosage units, each of which comprises 2 mg of estradiol valerate and 2 mg of dienogest, and a second group comprising 17 daily oral dosage units, each of which comprises 2 mg of estradiol valerate and 3 mg of dienogest; a third phase of 2 daily oral dosage units, each comprising 1 mg of estradiol valerate, and a fourth phase of 2 daily oral dosage units, each comprising a pharmaceutically acceptable placebo. 6. The method of claim 5, comprising six of said treatment cycles of 28 days.