Multi-phase contraceptive preparation based on a natural estrogen
DC CAFC
First Claim
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, anda fourth phase of 2 two daily dosage units, each comprising a pharmaceutically acceptable placebo.
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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.
30 Citations
3 Claims
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1. A multiphase product for contraception comprising:
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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.
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2. A multiphase oral contraception product comprising:
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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.
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3. A method of oral contraception comprising orally administering to a woman:
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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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Specification
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- Resources
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Current AssigneeBayer Intellectual Property GmbH (Bayer AG)
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Original AssigneeBayer Pharma AG (Bayer AG)
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InventorsEndrikat, Jan, Duesterberg, Bernd
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Primary Examiner(s)HUI, SAN MING R
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Application NumberUS11/578,771Publication NumberTime in Patent Office2,426 DaysField of Search514/170, 514/182US Class Current514/170CPC Class CodesA61K 31/00 Medicinal preparations cont...A61K 31/56 Compounds containing cyclop...A61K 31/57 substituted in position 17 ...A61P 15/00 Drugs for genital or sexual...A61P 15/18 Feminine contraceptivesA61P 5/24 of the sex hormones
