Progestin therapy for maintaining amenorrhea

Abstract

The present invention teaches that daily, cyclical vaginal delivery of progestin may be used to provide regular, predictable withdrawal bleeding during hormone replacement therapy. The present invention also teaches that constant administration of progestin in a water-insoluble, water-swellable cross-linked polycarboxylic acid polymer may be used to maintain amenorrhea. Either regimen is accompanied by a significant decrease in adverse side effects.

We claim:  
     
         1 . A method of promoting regular withdrawal bleeding in a woman undergoing cyclical progestin administration comprising cyclical vaginal delivery of progestin via a drug delivery system in an amount sufficient to cause secretory transformation of the endometrium while avoiding significant adverse side effects.  
     
     
         2 . The method of    claim 1    wherein the drug delivery system comprises a water-insoluble, water-swellable cross-linked polycarboxylic acid polymer.  
     
     
         3 . The method of    claim 2    wherein the polymer is polycarbophil.  
     
     
         4 . The method of    claim 3    wherein the progestin is progesterone.  
     
     
         5 . The method of    claim 4    wherein the amount of progesterone delivered is about 45 mg to about 90 mg per dose.  
     
     
         6 . The method of    claim 4    wherein the drug delivery system additionally comprises at least one adjuvant.  
     
     
         7 . The method of either of claims  2  and  5  wherein the drug delivery system is administered daily during a set portion of every calendar month.  
     
     
         8 . The method of    claim 3    wherein the woman is also being treated with estrogen.  
     
     
         9 . The method of    claim 7    wherein the woman is also being treated with estrogen.  
     
     
         10 . A method of maintaining amenorrhea in a woman undergoing constant progestin administration comprising constant vaginal administration of progestin via a drug delivery system in an amount sufficient to cause endometrial atrophy while avoiding significant adverse side effects.  
     
     
         11 . The method of    claim 10    wherein the drug delivery system comprises a water-insoluble, water-swellable cross-linked polycarboxylic acid polymer.  
     
     
         12 . The method of    claim 11    wherein the polymer is polycarbophil.  
     
     
         13 . The method of either of claims  10  and  12  wherein the progestin is progesterone.  
     
     
         14 . The method of    claim 10    wherein the progestin is administered about twice per week.  
     
     
         15 . The method of    claim 13    wherein the progestin is administered about twice per week.