Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
AssigneeDuramed Pharmaceuticals, Inc.
InventorsCharles DiLiberti, Kathleen Reape, Lance Bronnenkant
Life of this patent
Estimating the term…
Abstract
The present invention provides ascending-dose extended cycle regimens in which a female is administered an estrogen and a progestin for a period of greater than 30 or 31 consecutive days, optionally followed by a hormone-free period or by a period of administration of estrogen. The disclosed regimens can be administered to a female to provide contraceptive and non-contraceptive benefits.
Claims65
A method of contraception, the method comprising:
- administering to a female in need thereof an estrogen and a progestin for a period of greater than 30 consecutive days,
- wherein the estrogen and progestin are administered in at least three phases,
- wherein a daily dosage of estrogen in a second phase is equal to or higher than a daily dosage of estrogen in a first phase,
- wherein a daily dosage of estrogen in a third phase is equal to or higher than the daily dosage of estrogen in the second phase,
- wherein a total daily dosage of estrogen and progestin in the second phase is higher than a total daily dosage of estrogen and progestin in the first phase, and
- wherein a total daily dosage of estrogen and progestin in the third phase is higher than the total daily dosage of estrogen and progestin in the second phase.
21-50. (canceled)
52-54. (canceled)
60-61. (canceled)
64-67. (canceled)
A method of contraception, the method comprising:
- administering to a female in need thereof an estrogen and a progestin for a period of greater than 30 consecutive days,
- wherein the estrogen and progestin are administered in at least two phases,
- wherein a total daily dosage of estrogen and progestin in a second phase is higher than a total daily dosage of estrogen and progestin in a first phase, and
- wherein a daily dosage of progestin in the second phase is less than twice a daily dosage of progestin in the first phase.
80-93. (canceled)
95-97. (canceled)
103-104. (canceled)
107-110. (canceled)
A pharmaceutical kit comprising:
- a first vaginal ring capable of providing a daily dosage of estrogen and a daily dosage of progestin;
- a second vaginal ring capable of providing a daily dosage of estrogen that is equal to or higher than that of the first vaginal ring and capable of providing a total daily dosage of estrogen and progestin that is higher than that of the first vaginal ring;
- and
- a third vaginal ring capable of providing a daily dosage of estrogen that is equal to or higher than that of the second vaginal ring and capable of providing a total daily dosage of estrogen and progestin that is higher than that of the second vaginal ring;
- wherein the vaginal rings are capable of providing estrogen and progestin for a period of greater than 30 consecutive days.
A pharmaceutical kit comprising:
- a first vaginal ring capable of providing a daily dosage of estrogen and a daily dosage of progestin;
- a second vaginal ring capable of providing a total daily dosage of estrogen and progestin that is higher than that of the first vaginal ring and capable of providing a daily dosage of progestin that is less than twice that of the first vaginal ring;
- wherein the vaginal rings are capable of providing estrogen and progestin for a period of greater than 30 consecutive days.
A pharmaceutical kit comprising:
- a first transdermal device capable of providing a daily dosage of estrogen and a daily dosage of progestin;
- a second transdermal device capable of providing a daily dosage of estrogen that is equal to or higher than that of the first transdermal device and capable of providing a total daily dosage of estrogen and progestin that is higher than that of the first transdermal device;
- and
- a third transdermal device capable of providing a daily dosage of estrogen that is equal to or higher than that of the second transdermal device and capable of providing a total daily dosage of estrogen and progestin that is higher than that of the second transdermal device;
- wherein the transdermal devices are capable of providing estrogen and progestin for a period of greater than 30 consecutive days.
A pharmaceutical kit comprising:
- a first transdermal device capable of providing a daily dosage of estrogen and a daily dosage of progestin;
- a second transdermal device capable of providing a total daily dosage of estrogen and progestin that is higher than that of the first transdermal device and capable of providing a daily dosage of progestin that is less than twice that of the first transdermal device;
- wherein the transdermal devices are capable of providing estrogen and progestin for a period of greater than 30 consecutive days.
A pharmaceutical kit comprising:
- a first oral dosage capable of providing a daily dosage of estrogen and a daily dosage of progestin;
- a second oral dosage capable of providing a daily dosage of estrogen that is equal to or higher than that of the first oral dosage and capable of providing a total daily dosage of estrogen and progestin that is higher than that of the first oral dosage;
- and
- a third oral dosage capable of providing a daily dosage of estrogen that is equal to or higher than that of the second oral dosage and capable of providing a total daily dosage of estrogen and progestin that is higher than that of the second oral dosage;
- wherein the oral dosages are capable of providing estrogen and progestin for a period of greater than 30 consecutive days.
A pharmaceutical kit comprising:
- a first oral dosage capable of providing a daily dosage of estrogen and a daily dosage of progestin;
- a second oral dosage capable of providing a total daily dosage of estrogen and progestin that is higher than that of the first oral dosage and capable of providing a daily dosage of progestin that is less than twice that of the first oral dosage;
- wherein the oral dosages are capable of providing estrogen and progestin for a period of greater than 30 consecutive days.
Dependencies are inferred from the claim text.