Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same
View Patent ↗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.
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.