Claims for Patent: 12,233,074

Summary for Patent: 12,233,074

Title:	Contraceptive methods with improved pearl index
Abstract:	Described are methods of providing contraception in a woman having a BMI≥30.0 kg/m2, comprising: selecting a woman determined to have a BMI≥30.0 kg/m2, and then orally administering to the selected woman a therapeutically effective amount of an estetrol component at a daily dose of from 14 mg to 16 mg, based on the estetrol moiety, and drospirenone at a daily dose of from 2.5 mg to 3.5 mg. Also described are methods of contraception that achieves a Pearl Index of <5 in women having a BMI≥30.0 kg/m2, comprising: selecting a woman determined to have a BMI≥30.0 kg/m2, and then orally administering to the selected woman a therapeutically effective amount of an estetrol component at a daily dose of from 14 mg to 16 mg, based on the estetrol moiety, and drospirenone at a daily dose of from 2.5 mg to 3.5 mg, wherein the method comprises daily administration of the estetrol component and drospirenone on 24 consecutive days followed by a hormone-free period of 4 consecutive days.
Inventor(s):	Jean-Michel Foidart, Maud JOST
Assignee:	Estetra SRL
Application Number:	US18/107,703
Patent Claims:	1. A method of contraception that achieves a Pearl Index of <2.5 in women 16-25 years old having a BMI≥30.0 kg/m2, comprising: selecting a woman 16-25 years old and determined to have a BMI≥30.0 kg/m2, and then orally administering to the selected woman a therapeutically effective amount of an estetrol component comprising an estetrol moiety at a daily dose of from 14 mg to 16 mg, based on the estetrol moiety, and drospirenone at a daily dose of from 2.5 mg to 3.5 mg, wherein the method comprises daily administration of the estetrol component and drospirenone on 24 consecutive days followed by a hormone-free period of 4 consecutive days. 2. The method of claim 1, further comprising, prior to the selecting, calculating the BMI of the woman from a measured height and weight of the woman. 3. The method of claim 1, wherein the selecting comprises selecting a woman determined to have a BMI≥30.0 kg/m2 and ≤35.0 kg/m2. 4. The method of claim 1, wherein the method has a Pearl Index of <1. 5. The method of claim 4, wherein the method comprises 12 cycles of daily administration of the estetrol component and drospirenone on 24 consecutive days, followed by a hormone-free period of 4 consecutive days. 6. The method of claim 4, wherein the method comprises 12 consecutive 28-day cycles of daily administration of the estetrol component and drospirenone on consecutive days 1-24 followed by a hormone-free period without administration of the estetrol component and drospirenone on consecutive days 25-28. 7. The method of claim 1, wherein the estetrol component is estetrol monohydrate. 8. The method of claim 1, wherein the estetrol component is estetrol monohydrate and is administered at a daily dose of 15 mg, based on the estetrol moiety, and the drospirenone is administered at a daily dose of 3 mg.