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-10772897-B2
Publication Date
2020-09-15
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 by administering a progestogen agent or a progesterone receptor modulator, such as ulipristal acetate or a metabolite thereof, to a woman within 72 hours before intercourse or within 120 hours after intercourse. This administration can be repeated at least once a week or at least twice a month depending on timing relative to intercourse. The method targets women, especially those who do not have regular sexual activity, offering contraception without requiring continuous daily medication.
The problem addressed is that conventional hormonal contraception requires daily intake regardless of intercourse frequency, which is inconvenient for women with infrequent sexual activity. Existing contraception methods do not meet the need for on-demand, coitus-dependent contraceptives that reduce exposure to hormones. Women sometimes improvise on-demand contraception by using available hormonal agents, but no established method and preferred agents for on-demand use have been provided until this invention.
Claims Coverage
The patent includes one primary independent claim covering a method of contraception with specific administration of ulipristal acetate and related features. The inventive features from this claim include the dosage, timing after intercourse, frequency of administration, and formulation.
Administration of ulipristal acetate within 120 hours after unprotected intercourse
Administering a tablet containing 20 mg to 30 mg of ulipristal acetate to a woman within 120 hours after an unprotected intercourse.
Timing of tablet administration beyond 72 hours and up to 120 hours post-intercourse
The tablet can specifically be administered more than 72 hours and up to 120 hours after the unprotected intercourse, broadening the window for effective contraception.
Repeated administration during menstrual cycle
The administration of ulipristal acetate can be repeated at least twice during a menstrual cycle for effective contraception.
Oral tablet formulation
The contraceptive is administered as an oral tablet.
Immediate-release oral tablet
The oral tablet is an immediate-release formulation to ensure timely drug availability.
The independent claim mainly covers on-demand contraception using specific doses of ulipristal acetate taken orally within 120 hours after intercourse, with provisions for repeated administration during the menstrual cycle and specifying immediate-release oral tablets as the formulation.
Stated Advantages
Provides an effective contraceptive method that can be used on-demand rather than requiring continuous daily use.
Reduces exposure to hormonal agents by allowing administration only when needed, beneficial especially for women with infrequent sexual activity.
Offers flexibility in timing with administration possible within 72 hours before or 120 hours after intercourse.
Can be administered orally as an immediate-release tablet, facilitating easy and convenient use.
Documented Applications
On-demand contraception for women, especially those who do not have regular sexual activity.
Use of ulipristal acetate or other progestogen agents or progesterone receptor modulators for contraception within specified time frames relative to intercourse.
Repeated administration for regular contraception when sexual activity becomes more frequent.
Various administration routes including oral, buccal, sublingual, parenteral, transdermal, vaginal, and rectal delivery systems, including vaginal rings and gels.
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