CONCRETE DRAINAGE TRAY
Patent Information
- Application Number
- EA202591762
- Authority / Receiving Office
- EA · EA
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2025-03-27
- Filing Date
- 2025-06-17
- Publication Date
- 2026-09-24
- Estimated Expiration
- 2045-06-17
Smart Images

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Abstract
Claims
1. The use of a composition formulated as an oral dosage unit for the relief of symptoms of estrogen deficiency in a subject with impaired liver function, wherein said composition contains an estetrol component, wherein said composition is administered in a daily amount equivalent to 15 to 20 mg of estetrol, and wherein the subject with impaired liver function is characterized by mild liver dysfunction, classified according to the Child-Pugh scale with a score of 5 or 6 points, or moderate liver dysfunction, classified according to the Child-Pugh scale with a score of 7-9 points.
2. The use according to claim 1, wherein the symptoms of estrogen deficiency are symptoms associated with menopause in a woman, during menopause, perimenopause or postmenopause.
3. Use according to claim 1 or 2 for reducing the frequency of vasomotor symptoms (VMS), the severity of VMS, the weekly weighted score of hot flashes, vaginal dryness, dyspareunia, or any combination thereof, or for use to improve quality of life according to the Menopausal Syndrome Severity Rating (MRS) and / or the Menopause Quality of Life Questionnaires (MENQOL).
4. The use according to claim 3, wherein the VMS are selected from hot flashes, sweating attacks, night sweats, chills, increased sweating, palpitations and combinations thereof.
5. Use according to any of the preceding paragraphs to alleviate the emotional aspects of the menopausal transition selected from depression, irritability, mood changes, insomnia, sleep disturbances, anxiety, nervous tension and combinations thereof.
6. Use according to any of the preceding paragraphs for the relief of physiological aspects of the menopausal transition selected from joint pain, loss of bone density, urinary tract infections, urinary incontinence, vaginal dryness, uterine prolapse, changes in skin texture, weight gain, dyspareunia, cardiovascular disease, diabetes, and combinations thereof.
7. The use according to any of the preceding claims, wherein a single administration of an oral dosage unit provides to a subject with impaired liver function a pharmacokinetic profile characterized by a geometric mean (GM) Cmax for estetrol (E4) that is less than 2 times the corresponding GM Cmax in a subject with normal liver function, preferably wherein the geometric mean (GM) Cmax is 1.7 times or less the corresponding GM Cmax in a subject with normal liver function.
8. The use according to any of the preceding paragraphs, wherein a single administration of the oral dosage unit provides to a subject with impaired liver function a pharmacokinetic profile characterized by a GM AUCinf for E4 that is less than 2 times the corresponding GM AUCinf in a subject with normal liver function, preferably wherein the GM AUCinf for E4 is 1.1 times or less the corresponding GM AUCinf in a subject with normal liver function.
9. The use according to any of the preceding claims, wherein a single administration of the oral dosage unit provides to a subject with impaired liver function a pharmacokinetic profile characterized by a GM AUCinf for E4-3 glucuronide that is not significantly different from the corresponding GM AUCinf of E4-3 glucuronide in a subject with normal liver function.
10. The use according to any of the preceding claims, wherein a single administration of an oral dosage unit provides to a subject with impaired liver function a pharmacokinetic profile characterized by a GM T1 / 2 for E4 that is the same as the corresponding GM T1 / 2 in a subject with normal liver function.
11. The use according to any of the preceding paragraphs, where the number, frequency and / or severity of adverse events do not differ between the population of subjects with impaired liver function and the population of subjects with normal liver function.
12. The use according to any of the preceding claims, wherein the estetrol component is estetrol monohydrate, preferably wherein the estetrol component is 15 or 20 mg of estetrol monohydrate.
13. The use according to any of the preceding claims, wherein the composition further comprises a progestogen component, preferably wherein the progestogen component is selected from the group consisting of progesterone, drospirenone, norethisterone, norethisterone acetate (NETA), dydrogesterone, levonorgestrel (LNG), etonogestrel, norgestrel, nomegestrol, nomegestrol acetate (NOMAC), trimegestone, nestorone, dydrogesterone, gestodene, desogestrel, norgestimate, cyproterone acetate, dienogest and chlormadinone, or wherein the composition further comprises bazedoxifene.
14. The use according to claim 13, wherein the progestogen component is drospirenone, preferably from 1 to 4 mg drospirenone, more preferably 3 mg drospirenone, or wherein said progestogen component is administered in an amount equivalent to from 1 to 4 mg drospirenone, preferably in an amount equivalent to 3 mg drospirenone.
15. The use according to any of the preceding claims, wherein the composition is formulated to correspond to a daily dosage unit.