Method of providing birth control

Abstract

The present disclosure describes a vaginal system comprising segesterone acetate and ethinyl estradiol configured for thirteen 28-day product-use cycles that is compatible with male condoms comprising natural rubber latex, polyisoprene, or polyurethane and a method of providing birth control using the vaginal system wherein a secondary contraception is employed when the vaginal system is removed or expelled from the vagina for specified amounts of time during any of the product-use cycles.

1 . A reusable contraceptive ring system for preventing pregnancy comprising:
 a) a toroidal-shaped ring body comprising a methyl siloxane-based polymer, the ring body having an overall diameter of 56 mm and a cross-sectional diameter of 8.4 mm, the ring body further having two essentially parallel channels, each channel having a diameter of 3.0 mm;   b) two active pharmaceutical ingredient-containing cores, wherein collectively the active pharmaceutical ingredient-containing cores contain 103 mg of segesterone acetate and 17.4 mg of ethinyl estradiol and wherein each core has a diameter of 3.0 mm;   wherein the contraceptive ring system releases an average of approximately 0.15 mg/day of segesterone acetate and an average of approximately 0.013 mg/day of ethinyl estradiol for up to 13 cycles of 21 days each; and   wherein the contraceptive ring system achieves in a plasma sample of a female patient:
 i. a C max  of approximately 1,147 pg/ml +/−315 pg/ml of segesterone acetate over twenty-one days during the first system use cycle; 
 ii. a C max  of 363 pg/ml +/−133 pg/ml of segesterone acetate over twenty-one days during the third system use cycle; 
 iii. a C max  of 294 pg/ml +/−116 pg/ml of segesterone acetate over twenty-one days during the thirteenth system use cycle; 
 iv. a C max  of 129 pg/ml +/−39 pg/ml of ethinyl estradiol over twenty-one days during the first system use cycle; 
 v. a C max  of 60 pg/ml +/−32 pg/ml of ethinyl estradiol over twenty-one days during the third system use cycle; and 
 vi. a C max  of 39 pg/ml +/−16 pg/ml of ethinyl estradiol over twenty-one days during the thirteenth system use cycle. 
   
     
     
         2 . The contraceptive ring system of  claim 1 , wherein each of the channels has a length of about 27 mm. 
     
     
         3 . The contraceptive ring system of  claim 1 , further comprising a storage case. 
     
     
         4 . The contraceptive system of  claim 1 , wherein contraceptive efficacy of the active pharmaceutical ingredients is diminished when the system has been outside of the vagina for more than two cumulative hours during a twenty-one day use cycle. 
     
     
         5 . The contraceptive ring system of  claim 1 , wherein the first core contains approximately 50% segesterone acetate by mass. 
     
     
         6 . The contraceptive ring system of  claim 1 , wherein the second core contains approximately 40% segesterone acetate and approximately 12% ethinyl estradiol by mass. 
     
     
         7 . A method of providing birth control comprising inserting into the vagina of a female of reproductive potential, a reusable contraceptive ring system for preventing pregnancy, the reusable contraceptive ring comprising:
 a) a toroidal-shaped ring body comprising a methyl siloxane-based polymer, the ring body having an overall diameter of 56 mm and a cross-sectional diameter of 8.4 mm, the ring body further having two essentially parallel channels, each channel having a diameter of 3.0 mm;   b) two active pharmaceutical ingredient containing cores, wherein collectively the active pharmaceutical ingredient-containing cores contain 103 mg of segesterone acetate and 17.4 mg of ethinyl estradiol, and wherein each core has a diameter of 3.0 mm;   wherein the contraceptive ring system releases an average of approximately 0.15 mg/day of segesterone acetate and an average of approximately 0.013 mg/day of ethinyl estradiol for up to 13 cycles of 21 days each; and   wherein the contraceptive ring system achieves in a plasma sample of a female patient:
 i. a C max  of approximately 1,147 pg/ml +/−315 pg/ml of segesterone acetate over twenty-one days during the first system use cycle; 
 ii. a C max  of 363 pg/ml +/−133 pg/ml of segesterone acetate over twenty-one days during the third system use cycle; 
 iii. a C max  of 294 pg/ml +/−116 pg/ml of segesterone acetate over twenty-one days during the thirteenth system use cycle; 
 iv. a C max  of 129 pg/ml +/−39 pg/ml of ethinyl estradiol over twenty-one days during the first system use cycle; 
 v. a C max  of 60 pg/ml +/−32 pg/ml of ethinyl estradiol over twenty-one days during the third system use cycle; and 
 vi. a C max  of 39 pg/ml +/−16 pg/ml of ethinyl estradiol over twenty-one days during the thirteenth system use cycle. 
   
     
     
         8 . The method of  claim 7 , wherein each of the channels has a length of about 27 mm. 
     
     
         9 . The method of  claim 7 , wherein contraceptive efficacy of the active pharmaceutical ingredients is diminished when the system has been outside of the vagina for more than two cumulative hours during a twenty-one day use cycle. 
     
     
         10 . The method of  claim 7 , wherein the first core contains approximately 50% segesterone acetate by mass. 
     
     
         11 . The method of  claim 7 , wherein the second core contains approximately 40% segesterone acetate and approximately 12% ethinyl estradiol by mass. 
     
     
         12 . A method of providing birth control, the method comprising:
 (a) initially inserting into the vagina of a female of reproductive potential on either day 2, 3, 4, or 5 of the female's menstrual cycle, a vaginal system comprising:   a silicone elastomer ring body having an overall diameter of approximately 56 mm and a cross-sectional diameter of approximately 8.4 mm, a first channel within the ring body, the first channel having an diameter of approximately 3 mm, a second channel within the ring body, the second channel having a diameter of approximately 3 mm, a first core disposed within the first channel, the first core having a diameter of approximately 3 mm, a second core disposed within the second channel, the second core having a diameter of approximately 3 mm, 103 mg of segesterone acetate, and 17.4 mg ethinyl estradiol, wherein the 103 mg of segesterone acetate is distributed throughout the first core and the second core; and wherein one of the first or second cores contains the 17.4 mg of ethinyl estradiol;   wherein the system releases an average of approximately 0.15 mg/day of segesterone acetate and an average of approximately 0.013 mg/day of ethinyl estradiol in a 21-day first period as measured across thirteen 28-day product-use cycles; and   wherein the initial insertion on day 2, 3, 4, or 5 is the first day of the 21-day first period;   (b) removing the vaginal system on the day following the end of the 21-day first period;   (c) storing the removed vaginal system for a second period of between five and seven days including the removal date of step (d), wherein the 21-day first period and second period together comprise a product-use cycle; and   (d) repeating steps (a), (b), and (c) for a total of up to thirteen product-use cycles including a first product-use cycle, wherein each initial insertion of step (a) is performed at approximately the same time of day as in a previous product-use cycle,   provided that if the vaginal system is out of the female's vagina for more than two cumulative hours during any 21-day first period, a secondary contraception product that does not comprise estrogen is employed for 7 consecutive days following reinsertion of the vaginal system into the female's vagina.   
     
     
         13 . The method of  claim 12 , wherein each of the channels has a length of about 27 mm. 
     
     
         14 . The method of  claim 12 , wherein the first core contains approximately 50% segesterone acetate by mass. 
     
     
         15 . The method of  claim 12 , wherein the second core contains approximately 40% segesterone acetate and approximately 12% ethinyl estradiol by mass. 
     
     
         16 . A method of providing birth control, the method comprising:
 (a) initially inserting into the vagina of a female of reproductive potential on either day 2, 3, 4, or 5 of the female's menstrual cycle, a vaginal system comprising:   a silicone elastomer ring body having an overall diameter of approximately 56 mm and a cross-sectional diameter of approximately 8.4 mm, a first channel within the ring body, the first channel having an diameter of approximately 3 mm, a second channel within the ring body, the second channel having a diameter of approximately 3 mm, a first core disposed within the first channel, the first core having a diameter of approximately 3 mm, a second core disposed within the second channel, the second core having a diameter of approximately 3 mm, 103 mg of segesterone acetate, and 17.4 mg ethinyl estradiol, wherein the 103 mg of segesterone acetate is distributed throughout the first core and the second core; and wherein one of the first or second cores contains the 17.4 mg of ethinyl estradiol;   wherein the system releases an average of approximately 0.15 mg/day of segesterone acetate and an average of approximately 0.013 mg/day of ethinyl estradiol in a 21-day first period as measured across thirteen 28-day product-use cycles; and   wherein the initial insertion on day 2, 3, 4, or 5 is the first day of the 21-day first period;   (b) removing the vaginal system on the day following the end of the 21-day first period;   (c) storing the removed vaginal system for a second period of between five and seven days including the removal date of step (d), wherein the 21-day first period and second period together comprise a product-use cycle; and   (d) repeating steps (a), (b), and (c) for a total of up to thirteen product-use cycles including a first product-use cycle, wherein each initial insertion of step (a) is performed at approximately the same time of day as in a previous product-use cycle;   wherein   a secondary contraception product that does not comprise estrogen is employed until the vaginal system has been in the vagina for 7 consecutive days following reinsertion of the vaginal system into the female's vagina when the vaginal system is out of the vagina for more than two cumulative hours during any 21-day first period.   
     
     
         17 . The method of  claim 16 , wherein each of the channels has a length of about 27 mm. 
     
     
         18 . The method of  claim 16 , wherein the first core contains approximately 50% segesterone acetate by mass. 
     
     
         19 . The method of  claim 16 , wherein the second core contains approximately 40% segesterone acetate and approximately 12% ethinyl estradiol by mass.