|Title:||Methods of hormonal treatment utilizing extended cycle contraceptive regimens|
|Abstract:||The present invention provides extended cycle contraceptive regimens in which a female is administered a combined dosage form of estrogen and progestin. The disclosed extended cycle contraceptive regimens can be administered to a female as a method of providing non-contraceptive benefits.|
|Inventor(s):||Ben-Maimon; Carole S. (Merion, PA), Hait; Howard (Wilmington, DE), Reape; Kathleen Z. (Bryn Mawr, PA), Bronnenkant; Lance J. (Synder, NY)|
|Assignee:||Teva Women's Health, Inc. (Woodcliff Lake, NJ)|
|Filing Date:||May 03, 2004|
|Claims:||1. A method of increasing fertility in a perimenopausal female, said method consisting essentially of administering to the female a monophasic combination of estrogen and progestin for a period of 80-90 consecutive days, in which the daily amount of estrogen is equivalent to about 10 .mu.m to about 30 .mu.g of ethinyl estradiol and in which the daily amount of progestin is equivalent to about 0.05 mg to about 0.20 mg of levonorgestrel, followed by a hormone-free period of 5-8 consecutive days, wherein neither estrogen nor progestin is administered to the female, and wherein hormone-free placebo is administered during said hormone-free period of 5-8 consecutive days, followed by administration of an agent to induce ovulation in the perimenopausal female. |
2. The method of claim 1, wherein the combination of estrogen and progestin is administered for at least 84 consecutive days.
3. The method of claim 1, wherein said hormone-free placebo is administered for 7 consecutive days.
4. The method of claim 1, wherein the agent to induce ovulation in the female is selected from the group consisting of menotropins and clomiphene citrate.
5. The method of claim 4, wherein the daily amount of estrogen is equivalent to about 30 .mu.g of ethinyl estradiol, and the daily amount of progestin is equivalent to about 0.15 mg of levonorgestrel.
6. The method of claim 4, wherein said ovulation agent is a menotropin.
7. The method of claim 4, wherein said ovulation agent is clomiphene citrate.