Transdermal contraceptive hormones delivery
Inventors
Rossi, Thomas M. • Foegh, Marie • Kydonieus, Agis
Assignees
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Publication Number
US-9775848-B2
Publication Date
2017-10-03
Expiration Date
Abstract
Dosing regimen for transdermal delivery of hormones comprising a monthly treatment cycle with a fixed treatment interval and a variable rest interval.
Core Innovation
The invention relates to a method of preventing pregnancy in a woman using transdermal administration of contraceptively effective hormones during a calendar-month treatment cycle. During a three-week or four-week treatment interval, a progestin and an estrogen are transdermally administered by successive weekly applications of three or four transdermal hormone delivery treatment interval devices, one for each week of the treatment interval.
The rest of the calendar month is treated as a rest interval in which a low dose of the progestin and a low dose of the estrogen are transdermally administered by a low dose transdermal hormone delivery device. The rest interval device delivers between 25% and 75% of the amount of progestin and between 25% and 75% of the amount of estrogen as delivered by each treatment interval device, and menstruation is experienced during the rest interval as part of the calendar-month regimen.
The method further defines hormone selections and timing relationships for transdermal delivery. The estrogen is selected from one or more specified estrogen compounds, and the progestin is selected from one or more specified progestin compounds.
Claims Coverage
The document includes one explicit independent claim that defines the core method, with multiple dependent claims refining device and dosing relationships, including specific hormone selections, rest-interval dosing fractions, and kit concepts.
Calendar-month transdermal contraceptive method with treatment and rest intervals
During a treatment cycle based on a calendar month, transdermally administering a contraceptively effective amount of a progestin and an estrogen during a three-week or four-week treatment interval by successive weekly applications of three or four transdermal hormone delivery treatment interval devices, one for each week of the treatment interval; and transdermally administering low dose progestin and low dose estrogen throughout a rest interval that is the balance of the calendar month by application of a low dose transdermal hormone delivery device during the rest interval, wherein the rest interval device delivers between 25% and 75% of the amount of progestin and between 25% and 75% of the amount of estrogen as delivered by each treatment interval device, whereby the woman experiences menstruation during the rest interval.
Rest-interval dosing fraction refinement
The rest interval device delivers low dose progestin and low dose estrogen during the rest interval according to a specific fractional range chosen from discrete fractions of the amounts delivered during a treatment interval.
Rest interval device linked by hormone concentrations and reduced size
The rest interval device has the same hormone concentrations as each treatment interval device but is smaller by being a fraction of the treatment interval device size.
Selected estrogen compound for both treatment interval and rest interval devices
The estrogen used in the treatment interval device and the rest interval device is ethinyl estradiol.
Quantitative serum concentration range during each treatment interval
A treatment-interval device kit is formulated to deliver an average serum concentration of about 15 to about 65 pg/ml of ethinyl estradiol during each treatment interval in a woman or in a population of women.
Kit with multiple treatment interval devices and corresponding rest interval devices
A kit is provided for use with the method, including multiple one-week transdermal hormone delivery treatment interval devices delivering specified progestin and estrogen amounts and rest interval devices delivering between 25% and 75% of the weekly progestin and estrogen doses during the rest interval.
Overall, the claims cover a calendar-month transdermal contraceptive method that uses successive weekly progestin-and-estrogen treatment interval devices followed by a rest interval device delivering 25% to 75% of the treatment-interval hormone amounts, with menstruation occurring during the rest interval. Dependent coverage further specifies rest dosing fractions, a device relationship linking rest-interval and treatment-interval hormone concentrations and device size, selected hormone compounds, quantitative serum concentration targets for ethinyl estradiol, and kit formulations that support the regimen.
Stated Advantages
Attenuated withdrawal symptoms via gradually declining hormone levels across the cycle.
Documented Applications
Preventing pregnancy in a woman using a transdermal calendar-month regimen with a three-week or four-week treatment interval followed by a rest interval in which menstruation occurs.
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