Method for on-demand contraception
Inventors
Ulmann, Andre • GAINER, Erin • Mathe, Henri Camille • NIEMAN, Lynnette • Blithe, Diana
Assignees
Laboratoire HRA Pharma SAS • National Institutes of Health NIH • US Department of Health and Human Services
Publication Number
US-9616073-B2
Publication Date
2017-04-11
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, comprising administering a progestogen agent or a progesterone receptor modulator, such as 17a-acetoxy-11b-[4-N,N-dimethylamino-phenyl)-19-norpregna-4,9-diene-3,20-dione (ulipristal acetate) or a metabolite thereof, within 72 hours before intercourse or within 120 hours after intercourse. The administration can be repeated at least once a week or at least twice a month depending on timing relative to intercourse. This method enables contraception without the need for daily continuous hormonal intake, providing flexibility for women whose sexual activity is infrequent or irregular.
Hormonal contraception traditionally requires continuous, generally daily intake of pills regardless of sexual activity frequency. However, women with infrequent intercourse would benefit from a coitus-dependent method that reduces exposure to hormones by allowing administration only when intercourse is expected or has recently occurred. Existing emergency contraceptive pills were used by women in some regions as on-demand contraceptives, but such methods were not recognized or formally established. This invention addresses the unmet need for such convenient on-demand contraception.
Claims Coverage
There is one independent claim in the patent, covering the method of on-demand contraception using ulipristal acetate administered by oral route within specified time frames and dosing regimens.
Method of on-demand contraception with specified dosing and timing
The method comprises administering a unit dosage of 30 mg of ulipristal acetate orally to a woman within 120 hours after intercourse. This administration is repeated at least twice during the woman’s menstrual cycle, with doses not given on the same day and not more than 3 consecutive days during the cycle.
Weekly administration schedule
Ulipristal acetate is administered at least once a week during the menstrual cycle.
Administration restrictions to limit consecutive dosing days
Ulipristal acetate administration is limited to no more than two days in a row within the menstrual cycle.
Oral tablet form of administration
Ulipristal acetate is administered as a tablet.
The independent claim specifically covers an oral on-demand contraceptive regimen using 30 mg ulipristal acetate administered twice or more during a menstrual cycle within 120 hours after intercourse, with constraints on timing and frequency to avoid consecutive dosing exceeding three days, establish weekly dosing, and specifying tablet dosage form.
Stated Advantages
Provides contraception that can be taken only when needed, reducing the exposure to hormones compared to daily hormonal contraceptives.
Offers an advantageous option particularly for women with infrequent sexual activity who would benefit from coitus-dependent contraception.
Enables repeated use within a menstrual cycle with demonstrated safety and efficacy, as evidenced by clinical examples with no pregnancies observed.
Documented Applications
On-demand contraception for women who do not have regular sexual activity, allowing hormone administration within 72 hours before or 120 hours after intercourse.
Use of ulipristal acetate or other progestogen agents or progesterone receptor modulators as an oral contraceptive agent administered in an on-demand regimen.
Administration of contraceptive agents through various routes including oral, buccal, sublingual, parenteral, transdermal, vaginal, rectal, and vaginal devices like rings for contraception on-demand.
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