# US 11,896,602 B2 · Method for preventing pregnancy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,896,602 B2 - Document ID: US11896602B2 - Status: Granted - Kind: B2 - Application number: 17/937,215 - Filed: 2022-09-30 - Published: 2023-02-09 - Granted: 2024-02-13 - Earliest claimed: 2016-08-05 - Assignees: Estetra Srl - Applicants: Estetra Srl - Inventors: Maud Jost; Glwadys Rausin - Web page: https://patentgrep.com/patent/US11896602B2 ## CPC - A61K 31/585: containing lactone rings, e.g. oxandrolone, bufalin - A61K 31/565: not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol - A61K 31/566: having an oxo group in position 17, e.g. estrone - A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention relates to a method for the management of dysmenorrhea involving administration of an estrogenic component which is preferably selected from the group consisting of estetrol and estetrol-like compounds. Estetrol-like compounds have been surprisingly found to be capable of mitigating dysmenorrhea, either when used alone or in combination with progestogenic components, and this to an extent surpassing the effect obtained with other compositions and with a favourable side-effect profile compared to currently available methods. ## Claims ### Claim 1 A method for preventing pregnancy, comprising orally administering to a female subject a composition comprising from 15 to 25 mg estetrol and from 1 to 4 mg drospirenone, wherein administration of said composition does not result in a hemostatic change exceeding a boundary of a normal hemostatic range. ### Claim 2 (depends on 1) The method according to claim 1, wherein the subject has dysmenorrhea, and wherein administration of said composition results in preventing or alleviating symptoms of dysmenorrhea in the subject. ### Claim 3 A method for preventing pregnancy, comprising orally administering to a female subject a composition comprising from 15 to 25 mg estetrol and from 1 to 4 mg drospirenone, wherein administration of said composition does not result in an increased risk of developing venous thromboembolism (VTE) in the subject. ### Claim 4 A method for preventing pregnancy, comprising orally administering to a female subject a composition comprising from 15 to 25 mg estetrol and from 1 to 4 mg drospirenone, wherein the subject's risk of developing VTE associated with administration of said composition is lower as compared to the risk associated with administration of other combined oral contraceptives. ### Claim 5 (depends on 1) The method according to claim 1, wherein no hemostatic change that exceeds the boundaries of the normal hemostatic range occurs upon administration of the composition. ### Claim 6 (depends on 1) The method according to claim 1, wherein the normal hemostatic range is defined as a prediction interval that 95% of the target patient population falls into. ### Claim 7 (depends on 1) The method according to claim 1, wherein said hemostatic change is determined based on a change in any one or more of the following markers: SHBG, free TFPI, free and total Protein-S, Protein-S activity, CBG, Ceruloplasmin, antithrombin III, APC resistance, protein-C activity, D-dimer, Prothrombin, Prothrombin fragment 1+2, Factor VII, Factor VIII, von Willebrand factor, Factor II, PAI-I, t-PA, plasminogen, E-selectin, and fibrinogen. ### Claim 8 (depends on 1) The method according to claim 1, wherein said hemostatic change is determined based on a change in level of Protein-S or TFPI. ### Claim 9 (depends on 1) The method according to claim 1, wherein said hemostatic change is measured after one cycle of treatment, after two cycles of treatment or after three cycles of treatment. ### Claim 10 (depends on 1) The method according to claim 1, wherein the composition comprises from 15 to 20 mg estetrol. ### Claim 11 (depends on 1) The method according to claim 1, wherein the composition comprises about 15 mg estetrol. ### Claim 12 (depends on 1) The method according to claim 1, wherein the composition comprises about 20 mg estetrol. ### Claim 13 (depends on 1) The method according to claim 1, wherein the composition comprises about 3 mg drospirenone. ### Claim 14 (depends on 1) The method according to claim 1, wherein said estetrol is estetrol monohydrate. ### Claim 15 (depends on 1) The method according to claim 1, wherein said composition comprises about 15 mg of estetrol and about 3 mg of drospirenone. ### Claim 16 (depends on 1) The method according to claim 1, wherein said composition is administered for 21 to 24 days, followed by an administration-free period of about 7 to 4 days. ### Claim 17 A method of contraception that avoids hemostatic changes exceeding a boundary of a normal hemostatic range in a subject, comprising administering to the subject a combined oral contraceptive (COC) comprising from 15 to 25 mg estetrol and from 1 to 4 mg drospirenone. ### Claim 18 (depends on 17) The method according to claim 17, wherein the subject has dysmenorrhea, and wherein administration of said COC results in preventing or alleviating symptoms of dysmenorrhea in the subject. ### Claim 19 A method of contraception that avoids hemostatic changes exceeding a boundary of a normal hemostatic range in a subject, comprising administering to the subject a combined oral contraceptive (COC) comprising from 15 to 25 mg estetrol and from 1 to 4 mg drospirenone, wherein administration of said COC does not increase the subject's risk of developing VTE. ### Claim 20 (depends on 17) The method according to claim 17, wherein said composition comprises about 15 mg of estetrol and about 3 mg of drospirenone.