Method for on-demand contraception
Inventors
Ulmann, Andre • GAINER, Erin • Mathe, Henri Camille • Blithe, Diana • NIEMAN, Lynnette
Assignees
Laboratoire HRA Pharma SAS • US Department of Health and Human Services
Publication Number
US-10159681-B2
Publication Date
2018-12-25
Expiration Date
2030-04-13
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Abstract
The invention relates to a method for on-demand contraception, which method comprises administering a progestogen agent or progesterone receptor modulator, such as 17a-acetoxy-11b-[4-N,N-dimethylamino-phenyl)-19-norpregna-4,9-diene-3,20-dione (ulipristal acetate) in a woman, within 72 hours before an intercourse or within 120 hours after the intercourse.
Core Innovation
The invention provides a method for on-demand contraception in a woman by administering a progestogen agent or progesterone receptor modulator, such as ulipristal acetate, within 72 hours before intercourse or within 120 hours after intercourse. This method can be repeated at least once a week for administration before intercourse or at least twice a month for administration after intercourse. The administration is not continuous daily dosing but rather on-demand, timed in relation to sexual activity.
The background articulates a problem wherein existing hormonal contraceptives require continuous, often daily, administration regardless of sexual activity frequency. This can be disadvantageous for women with infrequent sexual intercourse, who would benefit from contraceptive preparations that depend on coitus and allow less frequent dosing, thereby reducing exposure to active ingredients. Despite recognition of the need for such on-demand contraception, it had remained unmet prior to this invention.
The invention further addresses the use of specific progestogen agents and progesterone receptor modulators, particularly ulipristal acetate, as an on-demand contraceptive regimen that can be administered orally or by other routes such as vaginal or transdermal. The invention elucidates effective dosage ranges, timing relative to intercourse, and the flexibility of repeated use within a menstrual cycle, providing a novel approach to contraception tailored for women with occasional sexual activity.
Claims Coverage
The claims encompass a method of contraception with several inventive features centered on the administration timing, dosage, and formulation of ulipristal acetate related to unprotected intercourse.
Timing of administration relative to intercourse
Administration of 20 mg to 30 mg of ulipristal acetate is performed within 72 hours and up to 120 hours after unprotected intercourse, allowing effective contraception in the extended postcoital period.
Extended window for postcoital administration
Ulipristal acetate can be administered more than 72 hours and up to 120 hours after unprotected intercourse, expanding the time frame for emergency contraception beyond previous limitations.
Oral solid dosage form delivery
The ulipristal acetate is administered as an oral solid dosage form, providing convenient and reliable delivery, specifically described as a tablet.
Immediate-release formulation for rapid action
The ulipristal acetate is provided in an immediate-release formulation, which facilitates quick bioavailability necessary for on-demand contraceptive effectiveness.
Together, these features define a contraceptive method that is on-demand, effective within an extended window post intercourse, administered in oral solid form, and designed for immediate release to provide timely contraceptive action.
Stated Advantages
Reduced exposure to contraceptive active ingredients owing to on-demand rather than daily administration.
Contraceptive method tailored for women with infrequent sexual activity, increasing convenience and acceptability.
Provides an option for contraception that can be used without continuous hormonal intake.
Enables repeated on-demand use within a menstrual cycle with demonstrated safety and efficacy.
Documented Applications
Use of progestogen agents or progesterone receptor modulators as an on-demand contraceptive method for women, particularly those with irregular or infrequent sexual activity.
Emergency contraception implemented by administering ulipristal acetate within 72 to 120 hours after unprotected intercourse.
Repeated administration of ulipristal acetate within a menstrual cycle for contraception on an as-needed basis.
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