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US 2016/0106759 A1Published application
Transdermal Delivery
AssigneeAgile Therapeutics, Inc.
InventorsThomas M. ROSSI, Marie FOEGH, Agis KYDONIEUS
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Abstract
Dosing regimen for transdermal delivery of hormones comprising a monthly treatment cycle with a fixed treatment interval and a variable rest interval.
Claims18
A method of preventing pregnancy in a woman that comprises, during a treatment cycle based on a calendar month:
- (A) transdermally administering a contraceptively effective amount of a progestin and an estrogen during a three-week treatment interval by successive applications of transdermal hormone delivery devices;
- and
- (B) 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 transermal hormone delivery device, wherein, in a given woman or population of women:
- the amount of progestin delivered during the treatment interval results in an average progestin serum concentration level equivalent to at least 500 pg/ml of levonorgestrel during the first week of the treatment interval and an average progestin serum concentration level equivalent to at least 750 pg/ml of levonorgestrel during the second and third weeks of the treatment interval;
- the amount of estrogen delivered during the treatment interval results in an average estrogen serum concentration level equivalent to at least 15 pg/ml of ethinyl estradiol during the treatment interval;
- the amount of the progestin delivered during the rest interval results in an average progestin serum concentration that is 25% to 75% the amount of the progestin delivered during the treatment interval;
- and
- the amount of the estrogen delivered during the rest interval results in an average estrogen serum concentration that is 25% to 75% the amount of the estrogen delivered during the treatment interval.
5 more elements
A kit comprising:
- (a) three, or a multiple of three, transdermal hormone delivery treatment devices, each treatment device comprising a progestin and an estrogen in an amount sufficient to reduce the risk of pregnancy, each being intended for wear for one week;
- (b) one rest interval device for each three treatment devices, intended for wear during a rest interval between successive three-week treatment intervals, wherein the rest interval device comprises:
- (1) low dose progestin in an amount sufficient to deliver an average progestin serum concentration that is 25% to 75% the amount of the progestin delivered during each week of the treatment interval, and (2) low dose estrogen in an amount sufficient to deliver an average estrogen serum concentration that is 25% to 75% the amount of the estrogen delivered during each week of the treatment interval;
- and
- (c) instructions for use of the devices in a calendar month treatment cycle comprising a three-week treatment interval and a rest interval comprising the balance of the calendar month.
2 more elements
Dependencies are inferred from the claim text.