Saturday, April 22, 2017 11:07:43 PM
1. A method for treating chronic estrogen-dependent hyperproliferation of uterine tissue according to an intermittent administration regimen comprising administering to a human female in need of such treatment a therapeutically effective amount of a selective progesterone receptor modulator (SPRM) selected from CDB-4124 (21-methoxy-17.alpha.-acetoxy-11.beta.-(4-N,N-dimethylaminophenyl)-19-nor- pregna-4,9-diene-3,20-dione) and 17.alpha.-acetoxy-11.beta.-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-d- iene-3,20-dione for an administration period during which the SPRM is administered daily consecutively over a period of from two to four months, then discontinuing said administration for a discontinuance period by means of a continual lack of treatment for a period of time sufficient for the female to undergo menstruation, said period of time being at least 32 days and equal to or less than the number of days during which the SPRM was previously administered, then administering a therapeutically effective amount of an SPRM daily consecutively over a period of from two to four months, then discontinuing said administration by means of continual lack of treatment for a period of time sufficient for the female to undergo menstruation, said period of time being at least 32 days and equal to or less than the number of days during which the compound was previously administered, and repeating this pattern of administration and discontinuance of administration for a sufficient duration to treat the chronic condition.
2. The method of claim 1, wherein the effective amount of SPRM is from 2 mg to 80 mg.
3. The method of claim 1, wherein the administration period is about three months.
4. The method of claim 3, wherein the administration period is about four months.
5. The method of claim 1, wherein the female is administered a progestin in an amount effective to induce menstruation during the discontinuance period.
6. The method of claim 5, wherein the female is administered a progestin selected from the group consisting of medroxyprogesterone, hydroxyprogesterone and progesterone.
7. The method of claim 1, wherein said compound is CDB-4124 (21-methoxy-17.alpha.-acetoxy-11.beta.-(4-N,N-dimethylaminophenyl)-19-nor- pregna-4,9-diene-3,20-dione).
8. The method of claim 7, wherein the administration period is about four months.
9. The method of claim 1, wherein the SPRM is 17.alpha.-acetoxy-11.beta.-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-d- ien-3,20-dione.
10. The method of claim 9, wherein the administration period is about three months.
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