Method, device, and kit for maintaining physiological levels of steroid hormone in a subject

• US 20110190201A1
• Filed: 03/10/2011
• Published: 08/04/2011
• Est. Priority Date: 07/24/2008
• Status: Abandoned Application

• Current Assignee: Deep Science LLC (Intellectual Ventures LLC)
• Original Assignee: Searete LLC (Intellectual Ventures LLC)
• Inventors: Ishikawa, Muriel Y., Wood, Lowell L. JR., Rivet, Dennis J., Hyde, Roderick A., Sweeney, Elizabeth A., Wood, Victoria Y.H.
• Application Number:
  US13/065,046
• Publication Number:
  US 20110190201A1
• Time in Patent Office: Days
• US Class Current: 514/6.9
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

A method, device, or kit is provided which maintain a substantially physiological cyclic pre-menopausal level of one or more steroid hormones in a mammalian subject in need thereof. The method, device, or kit includes providing to the subject at least one treatment regimen including replacement therapy for the one or more steroid hormones or metabolites or modulators thereof, wherein the at least one treatment regimen is determined based on pre-menopausal cyclic steroid hormone levels of the subject and on current cyclic steroid hormone levels of the subject, wherein the at least one treatment regimen is configured to maintain the subject'"'"'s one or more steroid hormones or metabolites or modulators thereof at substantially physiological cyclic pre-menopausal levels. The method, device, or kit can be used for the treatment of a disease or condition in the mammalian subject.

Claims

1-59. -59. (canceled)

60. A method for treating a metabolic disease in a mammalian subject comprising:

providing to the subject at least one treatment regimen including replacement therapy for the one or more steroid hormones or metabolites or modulators thereof, wherein the at least one treatment regimen is determined based on the subject'"'"'s pre-menopausal cyclic steroid hormone levels and on current cyclic steroid hormone levels.

61. The method of claim 60, wherein the at least one treatment regimen is configured to maintain the subject'"'"'s one or more steroid hormones or metabolites or modulators thereof at substantially physiological cyclic pre-menopausal levels in an amount effective to reduce or eliminate metabolic disease in the subject.

62. The method of claim 60, wherein the current cyclic steroid hormone levels are based on one or more of peri-menopausal, early menopausal, late menopausal, or post-menopausal steroid hormone levels of the subject.

63. The method of claim 61, wherein the metabolic disease includes at least one of diabetes, metabolic syndrome, or thyroid disease.

110. The method of claim 60, further comprising determining the one or more steroid hormones levels in the subject during a treatment period.

111. The method of claim 110, wherein the treatment period includes a time period preceding treatment or a time period during treatment with the at least one treatment regimen.

112. The method of claim 110, wherein the determining the one or more steroid hormones levels occurs at multiple time points during the treatment period.

113. The method of claim 110, further comprising providing to the subject at least one second treatment regimen adjusted to maintain the subject'"'"'s one or more steroid hormones or one or more metabolites or modulators thereof at substantially physiological cyclic pre-menopausal levels.

114. The method of claim 60, wherein the at least one treatment regimen is determined based at least in part on a time-history of serum steroid hormone levels in the subject, on inferred peak values or minimal values of serum steroid hormone levels in the subject, on age of the subject, or on categorization relative to profiles of patient populations.

115. The method of claim 60, wherein the at least one treatment regimen is determined based at least in part on Fourier analysis of the cyclic steroid hormone levels in the subject, or on harmonic analysis of the cyclic steroid hormone levels in the subject.

116. The method of claim 60, wherein the at least one treatment regimen is determined based on a genetic profile of the subject.

117. The method of claim 60, further comprising determining a genetic profile of the subject.

118. The method of claim 60, wherein the at least one treatment regimen is determined based at least in part on scaled values of the pre-menopausal cyclic steroid hormone levels in the subject.

119. The method of claim 118, wherein the at least one treatment regimen is determined based at least in part on a scaled value approximately equal to one.

120. The method of claim 118, wherein the at least one treatment regimen is determined based at least in part on a scaled value dependent on age of the subject.

121. The method of claim 60, wherein the subject is peri-menopausal, early menopausal, late menopausal, or post menopausal.

122. The method of claim 60, further comprising determining the subject'"'"'s one or more steroid hormones levels when the subject is premenopausal and has no underlying condition affecting production of steroid hormones.

123. The method of claim 122, wherein the at least one treatment regimen is determined based at least in part on a time-history of serum steroid hormone levels in the subject, on inferred peak values or minimal values of serum steroid hormone levels in the subject, on age of the subject, or on categorization relative to profiles of patient populations.

124. The method of claim 122, wherein the at least one treatment regimen is determined based on a genetic profile of the subject.

125. The method of claim 122, further comprising determining a genetic profile of the subject.

126. The method of claim 60, wherein the at least one treatment regimen is determined while the subject is not pre-menopausal.

127. The method of claim 60, wherein the at least one treatment regimen is determined while the subject has an underlying condition affecting production of hormones.

128. The method of claim 127, wherein the subject has undergone oopherectomy, and the at least one treatment regimen is determined based on the subject'"'"'s pre-surgical cyclic steroid hormone levels.

129. The method of claim 60, wherein the subject is female.

130. The method of claim 60, wherein the treatment regimen is provided orally.

131. The method of claim 60, wherein the treatment regimen is provided transdermally or subdermally.

132. The method of claim 60, wherein the hormones or their metabolically related compounds are sterols, androgens, testosterone, progestogens, estrogens, estradiol, estrone, follicle-stimulating hormone, luteinizing hormone, inhibin B, anti-Mullerian hormone thyroid-related hormones, or analogs or derivatives thereof.

133. The method of claim 132, wherein the androgen is testosterone.

134. The method of claim 132, wherein the estrogen is an estradiol or estrone.

135. The method of claim 60, wherein the at least one treatment regimen is determined based at least in part on one or more ratios of levels of the steroid hormones or metabolically related compounds in the subject, and the treatment regimen restores the one or more ratios to physiological cyclic pre-menopausal levels.

136. The method of claim 135, wherein the one or more ratios include a ratio of different estradiols, an estradiol to an estrone, or a testosterone to an estrogen.

137. The method of claim 135, wherein the one or more ratios include a ratio of the one or more steroid hormones or metabolically related compounds at different time intervals of the cycle in the subject.

138. The method of claim 60, further comprising determining one or more ratios of levels of the steroid hormones or metabolically related compounds in the subject.

139. The method of claim 60, wherein the at least one treatment regimen is determined based on the subject'"'"'s pre-menopausal cyclic levels of one or more steroid hormone receptors and on the subject'"'"'s current levels of the one or more steroid hormone receptors.

140. The method of claim 139, wherein the one or more hormone receptors is an estrogen receptor.

141. The method of claim 60, wherein the at least one treatment regimen is based on diagnostic data.

142. The method of claim 141, wherein the diagnostic data is based on serum levels of at least one of inflammation-related compounds, lipid-related compounds, or disease-related markers.

143. The method of claim 142, wherein the at least one inflammation-related compound is C-reactive protein.

144. The method of claim 142, wherein the at least one lipid-related compound includes a high density lipoprotein or a low density lipoprotein.

145. The method of claim 142, wherein the at least one disease-related marker includes a metabolic disease marker.

146. The method of claim 60, wherein the at least one treatment regimen is determined using an algorithm designed to determine a dosage of the one or more steroid hormones or metabolites, modulators, or analogs thereof in the at least one treatment regimen.

147. The method of claim 60, wherein the subject'"'"'s pre-menopausal cyclic steroid hormone levels or one or more of the subject'"'"'s peri-menopausal, early menopausal, late menopausal, or post-menopausal steroid hormone levels are determined for a period of time from at least approximately 7 days to approximately 168 days.

64-109. -109. (canceled)