Cyclic Progestin Regimens and Kits

Abstract

A method of contraception is provided which involves delivery of 21 to 27 consecutive days of a progestin in the absence of an estrogen or other steroidal compound, followed by 1 to 7 days without an effective amount of an active agent. Also described is a pharmaceutically useful kit to facilitate delivery of this regimen.

What is claimed is: 
     
         1 . A pharmaceutically useful kit adapted for daily oral administration, which comprises:
 (a) 21 to 27 daily dosage units of an effective amount of 5-(4,4-dimethyl-2-thioxo-1,4-dihydro-2H-benzo[d][1,3]oxazin-6-yl)-1-methyl-1H-pyrrole-2-carbonitrile; and   (b) one or more packages for said daily dosage units.   
     
     
         2 . The pharmaceutically useful kit according to  claim 1 , further comprising:
 (c) 1 to 7 daily dosage units of an orally and pharmaceutically acceptable placebo.   
     
     
         3 . The pharmaceutically useful kit according to  claim 2 , which comprises:
 (a) 21 daily dosage units of said 5-(4,4-dimethyl-2-thioxo-1,4-dihydro-2H-benzo[d][1,3]oxazin-6-yl)-1-methyl-1H-pyrrole-2-carbonitrile; and   (c) 7 daily dosage units of said orally placebo.   
     
     
         4 . The pharmaceutically useful kit according to  claim 2 , which comprises:
 (a) 23 daily dosage units of said 5-(4,4-dimethyl-2-thioxo-1,4-dihydro-2H-benzo[d][1,3]oxazin-6-yl)-1-methyl-1H-pyrrole-2-carbonitrile; and   (c) 5 daily dosage units of said placebo.   
     
     
         5 . The pharmaceutically useful kit according to  claim 2 , which comprises:
 (a) 25 daily dosage units of said 5-(4,4-dimethyl-2-thioxo-1,4-dihydro-2H-benzo[d][1,3]oxazin-6-yl)-1-methyl-1H-pyrrole-2-carbonitrile; and   (c) 3 daily dosage units of said placebo.   
     
     
         6 . The pharmaceutically useful kit according to  claim 2 , which comprises:
 a) 27 daily dosage units of said 5-(4,4-dimethyl-2-thioxo-1,4-dihydro-2H-benzo[d][1,3]oxazin-6-yl)-1-methyl-1H-pyrrole-2-carbonitrile; and   b) 1 daily dosage unit of said placebo.   
     
     
         7 . The pharmaceutically useful kit according to  claim 1 , wherein said daily dosage units are tablets. 
     
     
         8 . The pharmaceutically useful kit according to  claim 1 , wherein said daily dosage units are a topical cream or gel. 
     
     
         9 . The pharmaceutically useful kit according to  claim 2 , wherein said placebo lacks an effective amount of said progestin. 
     
     
         10 . The pharmaceutically useful kit according to  claim 1 , which lacks a second steroidal compound. 
     
     
         11 . The pharmaceutically useful kit according to  claim 1 , wherein said second steroidal compound is an estrogen. 
     
     
         12 . The pharmaceutically useful kit according to  claim 1 , wherein said effective amount is about 0.03 to about 0.6 mg. 
     
     
         13 . The pharmaceutically useful kit according to  claim 12 , wherein said effective amount is about 0.1 to about 0.5 mg. 
     
     
         14 . The pharmaceutically useful kit according to  claim 13 , wherein said effective amount is about 0.1. 
     
     
         15 . The pharmaceutically useful kit according to  claim 13 , wherein said effective amount is about 0.2 mg. 
     
     
         16 . The pharmaceutically useful kit according to  claim 13 , wherein said effective amount is about 0.3 mg. 
     
     
         17 . A pharmaceutically useful kit adapted for daily oral administration, consisting essentially of:
 (a) 21 to 27 daily dosage units of an effective amount of 5-(4,4-dimethyl-2-thioxo-1,4-dihydro-2H-benzo[d][1,3]oxazin-6-yl)-1-methyl-1H-pyrrole-2-carbonitrile; and   (b) one or more packages for said daily dosage units.   
     
     
         18 . The pharmaceutically useful kit according to  claim 17 , which lacks a second steroidal compound. 
     
     
         19 . A pharmaceutically useful kit adapted for daily oral administration, consisting of:
 (a) 21 to 27 daily dosage units of an effective amount of 5-(4,4-dimethyl-2-thioxo-1,4-dihydro-2H-benzo[d][1,3]oxazin-6-yl)-1-methyl-1H-pyrrole-2-carbonitrile; and   (b) one or more packages for said daily dosage units.