System for providing birth control

A vaginal system for preventing pregnancy, the system comprising:

• a) a methyl siloxane-based polymer ring body, the ring body having an overall diameter of 56 mm and a cross-sectional diameter of approximately 8 mm, and comprising:
• i. a first cylindrical channel having a length of approximately 27 mm and a diameter of approximately 3 mm wherein the channel is adapted to receive a first cylindrical core;
• ii. a second cylindrical channel having a length of approximately 27 mm and a diameter of approximately 3 mm wherein the channel is adapted to receive a second cylindrical core;
• and
• iii. TiO2;
• b) a first cylindrical core disposed within the first cylindrical channel, wherein the first cylindrical core has a diameter of approximately 3 mm and comprises at least one silicone elastomer, dibutyltin dilaurate, and a viscosity agent;
• c) a second cylindrical core disposed within the second cylindrical channel, wherein the second cylindrical core has a diameter of approximately 3 mm and comprises at least one silicone elastomer and dibutyltin dilaurate;
• and
• d) approximately 103 mg of segesterone acetate and approximately 17.4 mg of ethinyl estradiol, wherein both the segesterone acetate and ethinyl estradiol are contained within the cores and wherein the segesterone acetate has a particle size D90 of not more than 10 microns;
• wherein
• the methyl siloxane-based polymer ring body further comprises a plurality of ethinyl estradiol molecules covalently linked to the methyl siloxane-based polymer as shown in Formula I
• further wherein
• approximately 80% to approximately 90% of the ethinyl estradiol is recoverable from the system after approximately 18 months of storage at 25° C. and 60% relative humidity;
• and
• wherein the methyl siloxane-based polymer ring body has a shore A hardness of approximately 25 to approximately 30, a mean fatigue parallel to the cores of approximately 95%, and a mean fatigue perpendicular to the cores of approximately 98%;
• further wherein the contraceptive ring system achieves in a plasma sample of a female patient:
• i. a segesterone acetate Cmax of approximately 1,147 pg/mL+/−315 pg/mL over a twenty-one day first period during a first product-use cycle;
• ii. a segesterone acetate Cavg of approximately 191 pg/mL+/−34 pg/mL over a twenty-one day first period during a first product-use cycle;
• iii. a segesterone acetate AUC0-21 day of approximately 96.2 ng*hr/mL+/−16.9 ng*hr/mL over a twenty-one days first period during a first product-use cycle;
• iv. an ethinyl estradiol Cmax of approximately 129 pg/mL+/−39 pg/mL of ethinyl estradiol over a twenty-one day first period during the first product-use cycle;
• v. an ethinyl estradiol Cavg of approximately 44 pg/mL+/−19 pg/mL over a twenty-one day first period during the first product-use cycle;
• and
• vi. an ethinyl estradiol AUC0-21 day of approximately 22.2 ng*hr/mL+/−9.8 ng*hr/mL over a twenty-one day first period during the first product-use cycle.