Extended cycle multiphasic oral contraceptive method

Abstract

A multiphasic method of contraception comprising the steps of sequentially administering to a female of child bearing age a Phase I composition containing a progestogen in an amount equivalent to about 0.3 to about 1.5 mg norethiiidrpne acetate and an estrogen in an amount equivalent to about 5 to abo[mu]t 15 mcg of ethinyl estradiol for about 7 to about 14 days; a Phase II composition containing a progestogen in an amount equivalent to about 0.3 to about 1.5 mg of norethindrone acetate and an estrogen in an amount equivalent to about 10 to about 25 meg of ethinyl estradiol for about 14 to about 22 days; a Phase m composition containing a progestogen in an amount equivalent to about 0.3 to about 1.5 mg of norethindrone acetate and an estrogen in an amount equivalent to about 15 to about 35 meg of ethinyl estradiol for about 20 to about 31 days; and an optional Phase IV composition containing (i) an estrogen in an amount equivalent to about 5 to about 20 meg of ethinyl estradiol, or (ii) a placebo or a non-steroidal component, or (iii) a combination of (i) and (ii), for about 2 to about 8 days. The ethinyl estradiol equivalent amount of estrogen in each of the successive Phases II and III is at least 5 meg greater than the ethinyl estradiol equivalent amount of estrogen in the immediately-preceding phase.

Description

[0001] This application claims priority to US Provisional Application 60 / 778,067, filed March 2, 2006, and US Provisional Application 60 / 792,653, filed April 18, 2006, which are hereby incorporated by reference in their entirety. technical field [0001] The present invention relates to multi-phase estrogen / progestin contraceptive therapy that can be used for a longer period of time. In the multi-phase therapy of the present invention, the amount of estrogen administered in each successive phase of the first three phases is greater than the amount of estrogen administered in the preceding phase. The therapy of the present invention provides contraception, enabling the user to maintain control of the menstrual cycle. Multi-phase contraceptive kits for use in practicing the methods of the invention are also contemplated. technical background [0002] Contraceptive compositions comprising estrogenic and progestogenic compounds are known to be highly effective in controlling ov...

AI Technical Summary

Problems solved by technology

Although excessive breakthrough bleeding can be reduced with higher doses of estrogen, this inevitably carries a higher risk of adverse side effects of estrogen on clotting factors

Finally, once the breakthrough bleeding is controlled, the user will have functional amenorrhea

This will make it psychologically impossible for the user to confirm that they are not pregnant