US2011124611A1PendingUtilityA1
Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration
Est. expiryJul 16, 2023(expired)· nominal 20-yr term from priority
Inventors:Robert G. BellCarole Ben-MaimonBeata IskoldLance J. BronnenkantHoward HaitKathleen Z. Reape
A61P 7/06A61P 43/00A61P 5/30A61P 5/00A61P 3/10A61P 31/00A61P 25/08A61P 25/00A61P 35/00A61P 29/00A61P 25/06A61P 15/18A61P 15/12A61P 19/02A61P 17/00A61P 15/08A61P 19/10A61P 15/14A61K 31/56A61P 11/06A61K 31/567
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Claims
Abstract
The present invention provides contraceptive regimens in which a female is administered a combined dosage form of estrogen and progestin followed by a period of administration of estrogen. The disclosed contraceptive regimens can be administered to a female as a method of providing non-contraceptive benefits.
Claims
exact text as granted — not AI-modified1 - 142 . (canceled)
143 . A method of treating a catamenial symptom in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of more than 50 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 2 to 10 consecutive days,
wherein the estrogen that is administered in combination with progestin for the period of more than 50 consecutive days is administered in a daily amount equivalent to about 10 μg to about 30 μg of ethinyl estradiol, the estrogen that is administered for the period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 10 μg to about 30 μg of ethinyl estradiol, and the progestin that is administered for the period of more than 50 consecutive days is administered in a daily amount equivalent to about 0.02 mg to about 1.5 mg of levonorgestrel.
144 - 149 . (canceled)
150 . The method of claim 143 , wherein the female is a peri-menopausal female.
151 . The method of claim 143 , wherein the catamenial symptom is a symptom associated with asthma, rheumatoid arthritis, seizure disorders, multiple sclerosis, diabetes, or migraine headache.
152 - 237 . (canceled)
238 . The method of claim 143 , wherein the dosage comprising the combination of estrogen and progestin is administered for a period of 60 to 110 consecutive days.
239 . The method of claim 143 , wherein the dosage comprising the combination of estrogen and progestin is administered for a period of 81 to 89 consecutive days.
240 . The method of claim 239 , wherein the dosage comprising the combination of estrogen and progestin is administered for 84 consecutive days.
241 . The method of claim 143 , wherein the dosage consisting essentially of estrogen is administered for a period of 5 to 8 consecutive days.
242 . The method of claim 241 , wherein the dosage consisting essentially of estrogen is administered for 7 consecutive days.
243 . The method of claim 143 , wherein the dosage comprising the combination of estrogen and progestin is administered for 84 consecutive days, and the dosage consisting essentially of estrogen is administered for 7 consecutive days.
244 . The method of claim 143 , wherein the estrogen that is administered for the period of more than 50 consecutive days is administered in a daily amount equivalent to about 20 μg of ethinyl estradiol.
245 . The method of claim 143 , wherein the estrogen that is administered for the period of more than 50 consecutive days is administered in a daily amount equivalent to about 30 μg of ethinyl estradiol.
246 . The method of claim 143 , wherein the estrogen that is administered for the period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 10 μg of ethinyl estradiol.
247 . The method of claim 143 , wherein the estrogen that is administered for the period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 30 μg of ethinyl estradiol.
248 . The method of claim 143 , wherein the estrogen is ethinyl estradiol.
249 . The method of claim 143 , wherein the progestin that is administered for the period of more than 50 consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 0.20 mg of levonorgestrel.
250 . The method of claim 143 , wherein the progestin that is administered for the period of more than 50 consecutive days is administered in a daily amount equivalent to about 0.15 mg of levonorgestrel.
251 . The method of claim 143 , wherein the progestin that is administered for the period of more than 50 consecutive days is administered in a daily amount equivalent to about 0.10 mg of levonorgestrel.
252 . The method of claim 143 , wherein the progestin that is administered for the period of more than 50 consecutive days is levonorgestrel.
253 . The method of claim 143 , wherein the progestin that is administered for the period of more than 50 consecutive days is desogestrel.
254 . The method of claim 143 , wherein an antidepressant is administered (i) in combination with the dosage consisting essentially of estrogen for the period of 2 to 10 consecutive days, (ii) intermittently, (iii) one time, or (iv) once weekly.
255 . The method of claim 143 , wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of more than 50 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 2 to 10 consecutive days, are administered orally.
256 . The method of claim 143 , wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of more than 50 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 2 to 10 consecutive days, are administered transdermally.
257 . The method of claim 143 , wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of more than 50 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 2 to 10 consecutive days, are administered monophasic ally.
258 . A method of treating a catamenial symptom in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,
wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is administered in a daily amount of about 10 μg to about 30 μg of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is administered in a daily amount of about 10 μg of ethinyl estradiol, and the progestin that is administered in combination with estrogen for the period of 84 consecutive days is administered in a daily amount of about 0.05 mg to about 0.15 mg of levonorgestrel.
259 . A method of treating a catamenial symptom in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,
wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is administered in a daily amount of about 30 μg of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is administered in a daily amount of about 10 μg of ethinyl estradiol, and the progestin that is administered in combination with estrogen for the period of 84 consecutive days is administered in a daily amount of about 0.15 mg of levonorgestrel.
260 . A method of treating a catamenial symptom in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,
wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasically in a daily amount of about 30 μg of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is orally administered monophasically in a daily amount of about 10 μg of ethinyl estradiol, and the progestin that is administered in combination with estrogen for the period of 84 consecutive days is orally administered monophasically in a daily amount of about 0.15 mg of levonorgestrel.
261 . A method of treating a catamenial symptom in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,
wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is administered in a daily amount of about 20 μg of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is administered in a daily amount of about 10 μg of ethinyl estradiol, and the progestin that is administered in combination with estrogen for the period of 84 consecutive days is administered in a daily amount of about 0.10 mg of levonorgestrel.
262 . A method of treating a catamenial symptom in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,
wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasically in a daily amount of about 20 μg of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is orally administered monophasically in a daily amount of about 10 μg of ethinyl estradiol, and the progestin that is administered in combination with estrogen for the period of 84 consecutive days is orally administered monophasically in a daily amount of about 0.10 mg of levonorgestrel.
263 . A method of treating a catamenial symptom in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 21 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,
wherein the estrogen that is administered in combination with progestin for the period of 21 consecutive days is administered in a daily amount of about 20 μg of ethinyl estradiol, the estrogen that is administered for the period of 7 consecutive days is administered in a daily amount of about 10 μg of ethinyl estradiol, and the progestin that is administered for the period of 21 consecutive days is administered in a daily amount of about 0.15 mg of desogestrel.
264 . The method of claim 263 , wherein an antidepressant is administered (i) in combination with the dosage consisting essentially of estrogen for the period of 7 consecutive days, (ii) intelinittently, (iii) one time, or (iv) once weekly.
265 . The method of claim 263 , wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of 21 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 7 consecutive days, are administered orally.
266 . The method of claim 263 , wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of 21 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 7 consecutive days, are administered transdermally.
267 . The method of claim 263 , wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of 21 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 7 consecutive days, are administered monophasically.
268 . The method of claim 263 , wherein the female is a peri-menopausal female.
269 . The method of claim 263 , wherein the catamenial symptom is a symptom associated with asthma, rheumatoid arthritis, seizure disorders, multiple sclerosis, diabetes, or migraine headache.Cited by (0)
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