Contraceptive transdermal delivery of hormones
Inventors
Rossi, Thomas M. • Foegh, Marie • Kydonieus, Agis
Assignees
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Publication Number
US-9198876-B2
Publication Date
2015-12-01
Expiration Date
Abstract
Dosing regimen for transdermal delivery of hormones comprising a 28 day treatment cycle with a fixed treatment interval and a fixed rest interval.
Core Innovation
The invention relates to a method of preventing pregnancy in a woman using transdermal hormone delivery across a 28-day treatment cycle. The method includes a treatment interval and a rest interval, with contraceptively effective amounts of a progestin and an estrogen administered transdermally during the treatment interval by successive applications of transdermal hormone delivery devices.
During the rest interval, low dose progestin and low dose estrogen are transdermally administered throughout the rest interval by application of a transdermal hormone delivery device. Each treatment interval is three weeks and each rest interval is one week, with levonorgestrel as the progestin and ethinyl estradiol as the estrogen.
The amount of the progestin delivered during the treatment interval results in an average levonorgestrel serum concentration of at least 750 pg/ml, and the amount delivered during the rest interval results in an average levonorgestrel serum concentration that is 25% to 75% of the amount delivered during the treatment interval. Similarly, the amount of ethinyl estradiol delivered during the treatment interval results in an average ethinyl estradiol serum concentration of at least 15 pg/ml, and the amount delivered during the rest interval results in an average ethinyl estradiol serum concentration that is 25% to 75% of the amount delivered during the treatment interval.
The method is configured so that the woman experiences menstruation with attenuated symptoms of menstruation during the rest interval. The associated claim set further specifies device implementation, including successive applications and multiple wearable transdermal hormone delivery devices, together with peak and trough serum concentrations and rest-interval hormone delivery relationships to treatment-interval delivery.
Claims Coverage
The independent claim defines a contraceptive transdermal regimen during a 28-day treatment cycle with a progestin/estrogen treatment interval delivered by successive transdermal hormone delivery devices and a rest interval with low dose progestin/estrogen delivered throughout the rest interval. The scheme includes 3-week treatment and 1-week rest intervals, levonorgestrel and ethinyl estradiol, serum concentration relationships of 25% to 75% during rest relative to treatment, and an intended outcome of menstruation with attenuated symptoms during the rest interval.
Transdermal progestin/estrogen during treatment interval and low-dose during rest interval for contraception
A method of preventing pregnancy in a woman comprising, during a 28-day treatment cycle having a treatment interval and a rest interval, transdermally administering a contraceptively effective amount of a progestin and an estrogen during the treatment interval by successive applications of transdermal hormone delivery devices, and transdermally administering low dose progestin and low dose estrogen throughout the rest interval by application of a transdermal hormone delivery device, wherein menstruation during the rest interval has attenuated symptoms.
Three-week treatment interval and one-week rest interval with levonorgestrel and ethinyl estradiol serum concentration relationships
Each treatment interval is three weeks and each rest interval is one week, the progestin is levonorgestrel, the amount delivered during the treatment interval results in an average levonorgestrel serum concentration of at least 750 pg/ml, the amount delivered during the rest interval results in an average levonorgestrel serum concentration that is 25% to 75% of the treatment interval amount; the estrogen is ethinyl estradiol, the amount delivered during the treatment interval results in an average ethinyl estradiol serum concentration of at least 15 pg/ml, and the amount delivered during the rest interval results in an average ethinyl estradiol serum concentration that is 25% to 75% of the amount delivered during the treatment interval.
Successive transdermal hormone delivery device applications in the treatment interval and rest-interval low-dose device application
During the treatment interval, contraceptive progestin and estrogen are administered transdermally during successive applications of transdermal hormone delivery devices, and during the rest interval low dose progestin and low dose estrogen are administered transdermally throughout the rest interval by application of a transdermal hormone delivery device.
The claim coverage centers on a contraceptive transdermal regimen that delivers levonorgestrel and ethinyl estradiol at treatment-interval serum levels and delivers reduced amounts during a one-week rest interval, using transdermal hormone delivery devices across the 28-day cycle, with the stated goal that menstruation during the rest interval has attenuated symptoms.
Stated Advantages
Menstruation with attenuated symptoms of menstruation during the rest interval.
Documented Applications
Not explicitly described in patent.
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