Method for on-demand contraception

Inventors

Ulmann, AndreGAINER, ErinMathe, Henri CamilleBlithe, DianaNIEMAN, Lynnette

Assignees

Laboratoire HRA Pharma SASUS Department of Health and Human Services

Publication Number

US-9283233-B2

Publication Date

2016-03-15

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 that comprises administering a progestogen agent or a progesterone receptor modulator, such as ulipristal acetate or a metabolite thereof, to a woman either 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, respectively. The method allows for discontinuous administration, enabling the woman to use the contraception when needed rather than daily.

The problem being solved is the lack of suitable contraception methods for women who have infrequent sexual activity and prefer contraception dependent on coitus rather than continuous daily hormonal intake. Existing hormonal contraceptives require daily intake regardless of sexual frequency, which can unnecessarily increase exposure to effective ingredients for women with infrequent intercourse. Although on-demand contraception needs were recognized long ago and women have created improvised methods, a reliable, officially recognized on-demand contraceptive method remained unmet.

Claims Coverage

The patent contains one independent claim focusing on a specific method for contraception involving ulipristal acetate administration after intercourse. The main inventive features cover the timing, dosage, and form of administration of ulipristal acetate.

Method for contraception with ulipristal acetate administered 72 to 120 hours after intercourse

The main inventive feature is a method for contraception comprising administering 30 mg of ulipristal acetate to a woman more than 72 hours and up to 120 hours after an unprotected intercourse.

Oral administration route of ulipristal acetate

Ulipristal acetate is administered orally as a preferred embodiment.

Oral solid dosage form

The ulipristal acetate is administered as an oral solid dosage form, preferably as a compressed tablet.

Immediate-release formulation

The oral solid dosage form of ulipristal acetate is an immediate-release formulation.

The independent claim focuses on an on-demand contraception method using a specific dosage of ulipristal acetate administered orally within a defined time window after intercourse, with emphasis on oral solid immediate-release forms such as tablets.

Stated Advantages

Provides a reliable method of contraception for women with infrequent sexual activity by allowing administration only when needed rather than continuous dosing.

Reduces exposure to hormonal agents compared to daily contraceptive pills.

Enables use as on-demand contraception within specific time frames before or after intercourse.

The method is safe and efficacious as demonstrated by prior clinical studies with ulipristal acetate.

Documented Applications

On-demand contraception for women, especially those who do not have regular sexual activity.

Use of ulipristal acetate or similar progestogen agents or progesterone receptor modulators for contraception taken within 72 hours before or 120 hours after intercourse.

Discontinuous administration of contraceptives at least once a week or twice a month depending on timing relative to intercourse.

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