USRE43916E1 - Composition for contraception - Google Patents
Composition for contraception Download PDFInfo
- Publication number
- USRE43916E1 USRE43916E1 US11/388,172 US38817206A USRE43916E US RE43916 E1 USRE43916 E1 US RE43916E1 US 38817206 A US38817206 A US 38817206A US RE43916 E USRE43916 E US RE43916E
- Authority
- US
- United States
- Prior art keywords
- days
- gestagen
- pill
- drospirenone
- combination preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Definitions
- This invention relates to the common use of estrogens and gestagens for the production of a combination preparation for oral contraception and a corresponding pack containing this combination preparation.
- Combination preparations for oral contraception are already known, for example, Femovan® [DE-PS 2 546 062] or Marvelon® [DE-OS 2 361 120]. These preparations consist of 21 active ingredient-containing (estrogen/gestagen) dosage units and 7 active ingredient-free coated tablets (sugar pills; placebos). The dose to be administered daily is uniformly high in each case (so-called single-phase preparations) and produces the desired contraceptive effect in the entire intake period and in the intake pause or during the intake of the placebos. In most preparations, a 7-day interruption of the intake of active ingredient-containing dosage units was considered necessary until quite recently to trigger a reliable withdrawal bleeding and thus to achieve a satisfactory cycle control.
- a combination preparation for substitution therapy and contraception for females before menopause is known from EP-A-0 253 607.
- This combination preparation contains an estrogen from the group
- a thus selected composition is to offset hormonal irregularities in the transition phase of premenopause and to help alleviate the symptoms caused by the hormonal changeover of the female organism in this phase.
- Such a composition simultaneously assures a premenopausal female the contraceptive protection still necessary at this age.
- the lowest estrogen dose contained in an oral contraceptive on the market at this time is 20 ⁇ g of ethinylestradiol, combined with 150 ⁇ g of desogestrel (Mercilon).
- desogestrel Mercilon
- the cycle control of this preparation is, as expected, somewhat poorer in comparison to preparations with a higher estrogen dose, the high acceptance rate of Mercilon indicates a small clinical relevance of this drawback.
- the observation, made identically in several studies, of a lesser ovarial suppression of the preparation containing 20 ⁇ g of ethinylestradiol represents a clinically important problem.
- the object of this invention is an improved single-phase combination preparation for a female of reproductive age, who is not yet in premenopause, containing an estrogen and gestagen in each individual dosage unit, with the lowest possible estrogen content in each individual dosage unit, but also with a low total hormone content per administration cycle.
- premenopause and “menopause” are used within the scope of this invention in the meaning of the conventional definition, see, for example, “The Controversial Climacteric,” P. A. of Keep et al., Ed., MTP press (1981), e.g., p. 9.
- the daily hormone dose is kept to a very low level here, while the usual 21-day intake is extended by two or three days.
- the remaining 5 or 4 days of a cycle are preferably bridged over by placebos, to avoid intake errors, or by 5 or 4 intake-free days.
- this relates to the use of a composition comprising an estrogen selected from
- this invention relates to a combination product for oral contraception, which comprises
- An especially preferred combination preparation according to this invention comprises 23 dosage units, each containing 20 ⁇ g of ethinylestradiol and 75 ⁇ g of gestodene and 5 sugar pills or other indications to show that no dosage unit or a sugar pill is administered during the last 5 days of the menstrual cycle.
- the ovarian suppression was measured based on the level of the endogenous 17 ⁇ -estradiol level and the size of follicular structures. The results show that the 17 ⁇ -estradiol levels with 23-day intake of the test preparation were significantly lower (p ⁇ 0.05) in comparison to the 21-day administration ( FIG. 1 ).
- the combination preparation according to the invention thus achieves the effectiveness previously known for preparations with a daily content of 30 ⁇ g of ethinylestradiol, although the daily ethinylestradiol dose is 33% lower and also the total dose per cycle is 27% lower.
- the endogenous 17 ⁇ -estradiol levels are suppressed easily controllably in the case of the majority of the users of the 23-day preparation.
- Clinical symptoms such as breast tenseness, premenstrual syndrome and menstrual disorders, which can be attributed to increased and greatly fluctuating estrogen levels, are observed with the 23-day preparation with clearly lower frequency.
- an intake, extended by two (or three) days, of preparations containing 20 ⁇ g of ethinylestradiol in each daily dosage unit can produce the above-mentioned advantages, without the daily dose having to be raised to the previously largely used level of 30 ⁇ g of ethinylestradiol.
- an estrogen and gestagen for the use according to the invention or for a combination preparation according to the invention takes place completely analogously as it is already known for usual oral contraceptives with 21-day intake period of the active ingredients, such as, for example, Femovan® (ethinylestradiol/gestodene) or Microgynon® (ethinylestradiol/levonorgestrel).
- active ingredients such as, for example, Femovan® (ethinylestradiol/gestodene) or Microgynon® (ethinylestradiol/levonorgestrel).
- a pack containing a combination preparation according to the invention is also designed analogously to packs for already known oral contraceptives on the market with the variation that instead of the usual 21 dosage units containing the active components, now 23 or 24 such dosage units and 5 or 4 sugar pills are present or else contain other suitable indications that 5 or 4 days are to be bridged over until continuation of the intake of active ingredient-containing dosage units.
- EP-A 0 253 607 especially also to the statements there for determination of equivalent amounts of ethinylestradiol and 17 ⁇ -estradiol, on the one hand, and various gestagens, such as levonorgestrel, desogestrel, 3-ketodesogestrel and gestodene, on the other hand.
- FIG. 1 Area with the 17 ⁇ -estradiol (E2) level in groups of 30 females, who are treated with an oral contraceptive (75 ⁇ g of gestodene+20 ⁇ g of ethinylestradiol) in 21- or 23-day administration interval over three cycles.
- FIG. 2 Number of females in %, who showed follicular developments (maturation) (>13 mm diameter) with 21- or 23-day treatment with an oral contraceptive (75 ⁇ g of gestodene+20 ⁇ g of ethinylestradiol).
Abstract
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- 2.0 to 6.0 mg of 17β-estradiol and
- 0.020 mg of ethinylestradiol;
and a gestagen selected from - 0.25 to 0.30 mg of drospirenone and
- 0.1 to 0.2 mg of cyproterone acetate,
followed by 5 or 4 pill-free or sugar pill days.
Description
Claims (17)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/388,172 USRE43916E1 (en) | 1993-12-22 | 2006-03-24 | Composition for contraception |
Applications Claiming Priority (11)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE4344462A DE4344462C2 (en) | 1993-12-22 | 1993-12-22 | Composition for contraception |
DE4344462 | 1993-12-22 | ||
US08/268,996 US5583129A (en) | 1993-12-22 | 1994-06-30 | Composition for contraception |
US08/742,147 US5824667A (en) | 1993-12-22 | 1996-10-31 | Composition for contraception |
US09/503,952 USRE37564E1 (en) | 1993-12-22 | 2000-02-15 | Composition for contraception |
US09/504,084 USRE37838E1 (en) | 1993-12-22 | 2000-02-15 | Composition for contraception |
US10/080,617 USRE38253E1 (en) | 1993-12-22 | 2002-02-25 | Composition for contraception |
US19375802A | 2002-07-12 | 2002-07-12 | |
US91660004A | 2004-08-12 | 2004-08-12 | |
US11/388,172 USRE43916E1 (en) | 1993-12-22 | 2006-03-24 | Composition for contraception |
US11/892,969 USRE44159E1 (en) | 1993-12-22 | 2007-08-28 | Composition for contraception |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/742,147 Reissue US5824667A (en) | 1993-12-22 | 1996-10-31 | Composition for contraception |
Publications (1)
Publication Number | Publication Date |
---|---|
USRE43916E1 true USRE43916E1 (en) | 2013-01-08 |
Family
ID=6506206
Family Applications (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/268,996 Expired - Lifetime US5583129A (en) | 1993-12-22 | 1994-06-30 | Composition for contraception |
US08/742,147 Ceased US5824667A (en) | 1993-12-22 | 1996-10-31 | Composition for contraception |
US09/503,952 Expired - Lifetime USRE37564E1 (en) | 1993-12-22 | 2000-02-15 | Composition for contraception |
US09/504,084 Expired - Lifetime USRE37838E1 (en) | 1993-12-22 | 2000-02-15 | Composition for contraception |
US10/080,617 Expired - Lifetime USRE38253E1 (en) | 1993-12-22 | 2002-02-25 | Composition for contraception |
US11/388,172 Expired - Lifetime USRE43916E1 (en) | 1993-12-22 | 2006-03-24 | Composition for contraception |
US11/892,969 Expired - Lifetime USRE44159E1 (en) | 1993-12-22 | 2007-08-28 | Composition for contraception |
Family Applications Before (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/268,996 Expired - Lifetime US5583129A (en) | 1993-12-22 | 1994-06-30 | Composition for contraception |
US08/742,147 Ceased US5824667A (en) | 1993-12-22 | 1996-10-31 | Composition for contraception |
US09/503,952 Expired - Lifetime USRE37564E1 (en) | 1993-12-22 | 2000-02-15 | Composition for contraception |
US09/504,084 Expired - Lifetime USRE37838E1 (en) | 1993-12-22 | 2000-02-15 | Composition for contraception |
US10/080,617 Expired - Lifetime USRE38253E1 (en) | 1993-12-22 | 2002-02-25 | Composition for contraception |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/892,969 Expired - Lifetime USRE44159E1 (en) | 1993-12-22 | 2007-08-28 | Composition for contraception |
Country Status (21)
Country | Link |
---|---|
US (7) | US5583129A (en) |
EP (2) | EP1726308A3 (en) |
JP (4) | JPH09506888A (en) |
KR (1) | KR100369206B1 (en) |
CN (2) | CN100377713C (en) |
AT (1) | ATE344038T1 (en) |
CA (1) | CA2179728C (en) |
CZ (1) | CZ296387B6 (en) |
DE (2) | DE4344462C2 (en) |
DK (1) | DK0735883T3 (en) |
ES (1) | ES2276391T3 (en) |
HK (1) | HK1077743A1 (en) |
HU (1) | HUT74877A (en) |
NL (1) | NL300329I1 (en) |
NO (1) | NO316257B1 (en) |
NZ (1) | NZ278058A (en) |
PL (1) | PL187818B1 (en) |
PT (1) | PT735883E (en) |
RU (1) | RU2169567C2 (en) |
SK (1) | SK285965B6 (en) |
WO (1) | WO1995017194A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11376263B2 (en) | 2020-10-08 | 2022-07-05 | Fortress Biotech, Inc. | Cyproterone acetate compositions and uses thereof |
Families Citing this family (77)
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