METHODS OF INCREASING ENDOGENOUS LUTEINIZING HORMONE
Further according to the present disclosure, there are methods for promoting egg maturation in assisted reproductive technologies, such as in in vitro fertilization (IVF) or in an embryo transfer (ET) process. There are also methods for decreasing the rate of ovarian hyperstimulation syndrome (OHSS), providing comparable or improved pregnancy rates, decreasing the time to pregnancy, and inhibiting premature ovulation. The methods include the step of administering a therapeutically effective amount of an active pharmaceutical ingredient of 2-(N-acetyl-D-tyrosyl-trans-4-hydroxy-L-prolyl-L-asparaginyl-L-threonyl-L-phenylalanyl) hydrazinocarbonyl-L-leucyl-Nω-methyl-L-arginyl-L-tryptophanamide or a pharmaceutically acceptable salt thereof.
1 - 119 . (canceled)
120 . A method of increasing endogenous luteinizing hormone (LH) level in a woman in need thereof of, the method comprising:
administering to the woman an initial dose of about 0.00003 mg to 0.030 mg 2-(N-acetyl-D-tyrosyl-trans-4-hydroxy-L-prolyl-L-asparaginyl-L-threonyl-L-phenylalanyl) hydrazinocarbonyl-L-leucyl-Nω-methyl-L-arginyl-L-tryptophanamide, or a pharmaceutically acceptable salt thereof.
121 . The method of claim 1 , wherein the woman is infertile; anovulatory; of advanced maternal age; or is experiencing secondary ovarian failure, oligomenorrhea, amenorrhea, endometriosis, polycystic ovarian syndrome (PCOS), or anovulatory infertility not due to primary ovarian failure, or combinations of any of the foregoing.
122 . The method of claim 1 , wherein the woman is infertile; anovulatory; or of advanced maternal age; or combinations of any of the foregoing.
123 . The method of claim 1 , wherein the woman is experiencing secondary ovarian failure, oligomenorrhea, amenorrhea, endometriosis, polycystic ovarian syndrome (PCOS), or anovulatory infertility not due to primary ovarian failure, or combinations of any of the foregoing.
124 . The method of claim 1 , wherein the maximum endogenous LH level in blood occurs between about 12 hours and about 48 hours after administration of the initial dose.
125 . The method of claim 1 , wherein the maximum endogenous LH level in blood occurs between about 18 hours and about 48 hours after administration of the initial dose.
126 . The method of claim 1 , wherein the woman's endogenous LH level in blood is elevated for at least 48 hours after administration of the initial dose of 2-(N-acetyl-D-tyrosyl-trans-4-hydroxy-L-prolyl-L-asparaginyl-L-threonyl-L-phenylalanyl) hydrazinocarbonyl-L-leucyl-Nω-methyl-L-arginyl-L-tryptophanamide, or a corresponding amount of a pharmaceutically acceptable salt thereof, compared to the woman's endogenous LH level in blood prior to administration of the initial dose.
127 . The method of claim 1 , wherein the woman's endogenous LH level in blood is elevated between about 14 hours to about 84 hours after administration of the initial dose of 2-(N-acetyl-D-tyrosyl-trans-4-hydroxy-L-prolyl-L-asparaginyl-L-threonyl-L-phenylalanyl) hydrazinocarbonyl-L-leucyl-Nω-methyl-L-arginyl-L-tryptophanamide, or a corresponding amount of a pharmaceutically acceptable salt thereof, compared to the woman's endogenous LH level in blood prior to administration of the initial dose.
128 . The method of claim 1 , wherein the woman is administered an initial dose of 0.0003 mg to 0.030 mg of 2-(N-acetyl-D-tyrosyl-trans-4-hydroxy-L-prolyl-L-asparaginyl-L-threonyl-L-phenylalanyl) hydrazinocarbonyl-L-leucyl-Nω-methyl-L-arginyl-L-tryptophanamide, or a corresponding amount of a pharmaceutically acceptable salt thereof.
129 . The method of claim 1 , wherein the woman is administered an initial dose of 0.0003 mg to 0.015 mg of 2-(N-acetyl-D-tyrosyl-trans-4-hydroxy-L-prolyl-L-asparaginyl-L-threonyl-L-phenylalanyl) hydrazinocarbonyl-L-leucyl-Nω-methyl-L-arginyl-L-tryptophanamide, or a corresponding amount of a pharmaceutically acceptable salt thereof.