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Claims for Patent: 8,071,577

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Claims for Patent: 8,071,577

Title:Multi-phase contraceptive preparation based on a natural estrogen
Abstract: The multiphase preparation having higher contraceptive safety and reduced side effects is based on a combination of a natural oestrogen with dienogest or drospirenone. The multiphase preparation is characterized by a first phase consisting of 2 daily dose units of 3 mg of oestradiol valerate, a second phase consisting of 2 groups of daily dose units, wherein a first group is formed by 5 daily dose units each containing a combination of 2 mg of oestradiol valerate and at least two or three times an ovulation-inhibitory dose of dienogest or drospirenone and a second group is formed by 17 daily dose units each containing a combination of 2 mg of oestradiol valerate and at least three or four times the ovulation-inhibitory dose of dienogest or drospirenone, a third phase consisting of 2 daily dose units of 1 mg of oestradiol valerate, and a further phase consisting of 2 daily dose units of pharmaceutically acceptable placebo.
Inventor(s): Endrikat; Jan (Kirkland, CA), Duesterberg; Bernd (Oberkraemer, DE)
Assignee: Bayer Pharma Aktiengesellschaft (Berlin, DE)
Application Number:11/578,771
Patent Claims: 1. A multiphase product for contraception comprising: a first phase of 2 daily dosage units, each comprising 3 mg of estradiol valerate, a second phase of 2 groups of daily dosage units, a first group comprising 5 daily dosage units, each of which comprises 2 mg of estradiol valerate and 2 mg of dienogest, and a second group comprising 17 daily dosage units, each of which comprises 2 mg of estradiol valerate and 3 mg of dienogest; a third phase of 2 two daily dosage units, each comprising 1 mg of estradiol valerate, and a fourth phase of 2 two daily dosage units, each comprising a pharmaceutically acceptable placebo.

2. A multiphase oral contraception product comprising: 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.

3. A method of oral contraception comprising orally administering to a woman: one oral dosage unit comprising 3 mg of estradiol valerate daily for 2 days, then one oral dosage unit comprising 2 mg of estradiol valerate and 2 mg of dienogest daily for 5 days, then one oral dosage unit comprising 2 mg of estradiol valerate and 3 mg of dienogest daily for 17 days, then one oral dosage unit comprising 1 mg of estradiol valerate daily for 2 days, and then one oral dosage unit comprising a pharmaceutically acceptable placebo daily for 2 days.
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