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Methods of Hormonal Treatment Utilizing Ascending-Dose Extended Cycle Regimens

a hormonal treatment and progestin technology, applied in the direction of biocide, drug composition, sexual disorder, etc., can solve the problems of increasing the frequency of bleeding problems, the spectrum of side effects of progestin-only preparations is more varied, etc., and achieve the effect of reducing breakthrough bleeding

Inactive Publication Date: 2007-05-17
TEVA WOMENS HEALTH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0018] The ascending-dose extended cycle regimens provide a number of non-contraceptive benefits, as well as contraceptive benefits. For example, the present invention is also directed to a method of reducing breakthrough bleeding in a female in need thereof by administering to the female an ascending-dose extended cycle regimen disclosed herein.

Problems solved by technology

However, the progestin-only preparations have a more varied spectrum of side effects than do the combined preparations, especially more breakthrough bleeding.
Whereas the conventional 21 day pill packs with a 7 day placebo interval worked well when oral contraceptives were of higher dosage, as the doses have come down, for both the estrogen and progestin components, bleeding problems have increased in frequency, especially in the early months of oral contraceptive use, but even persistently so in some patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0198] Tables 2-6 below show examples of ascending-dose extended cycle regimens for 2-month, 3-month, 4-month, 5-month, and 6-month cycles, respectively. All regimens below comprise three phases, wherein an equivalent of 20 μg of ethinyl estradiol is administered in the first phase, 25 μg of ethinyl estradiol is administered in the second phase, and 30 μg of ethinyl estradiol is administered in the third phase. For all regimens below, an equivalent of 150 μg of levonorgestrel is administered in all three phases. For each regimen below, two possibilities are provided for phase 3, one corresponding to an allowance of 7 days of placebo following the administration of the estrogen and progestin, and the other corresponding to an allowance of 3 days of placebo following the administration of the estrogen and progestin.

TABLE 2Two-Month Ascending-Dose Extended Cycle RegimenNo. of days inTotal estrogenTotal progestinPhaseseach phasedose (μg)dose (μg)1142802215253 (with 7 days placebo14420...

example 2

[0204] A clinical study is contemplated, as follows, using ascending-dose extended cycle regimens in accordance with the present invention.

[0205] The primary objective of this study is to evaluate and compare bleeding patterns and hormone-related symptoms in women receiving one of the following three different ascending dose extended cycle (91-day) oral contraceptive regimens, each having combination active tablets containing ethinyl estradiol (EE) and levonorgestrel (LNG), followed by EE tablets during the seven-day interval between each 84-day cycle of combination therapy:

[0206] Regimen I: Subjects will utilize a regimen of 42 days combination active tablets (20 μg EE / 150 μg LNG) followed by 21 days combination active tablets (25 μg EE / 150 μg LNG) followed by 21 days combination active tablets (30 μg EE / 150 μg LNG) followed by 7 days of 10 μg EE tablets for two consecutive 91-day cycles.

[0207] Regimen II: Subjects will utilize a regimen of 21 days combination active tablets (20...

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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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation in part of U.S. application Ser. No. 11 / 245,471, filed Oct. 7, 2005, which claims the benefit of U.S. Provisional Application No. 60 / 616,424, filed Oct. 7, 2004, and U.S. Provisional Application No. 60 / 684,568, filed May 26, 2005, the contents of which are hereby incorporated by reference in their entireties.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to methods of hormonal treatment by ascending-dose extended administration of an estrogen and a progestin. [0004] 2. Related Art [0005] The human menstrual cycle involves a repetitive sequence of hormonal changes that result in episodic uterine bleeding. Normally, each menstrual cycle has a mean interval of 21 to 35 days, conventionally beginning with the first day of menstrual flow and ending on the day before the next onset of bleeding. Duration of the menstrual flow is usually 2 to 6 days with loss ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/57A61K31/56
CPCA61K31/56A61K31/567A61K31/57A61K2300/00A61P15/18A61P17/10A61P43/00A61K31/565
Inventor DILIBERTI, CHARLES E.REAPE, KATHLEEN Z.BRONNENKANT, LANCE J.
Owner TEVA WOMENS HEALTH
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