Claims for Patent: 10,780,047

Summary for Patent: 10,780,047

Title:	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.
Inventor(s):	Creasy, II; George William (Glen Gardner, NJ), Merkatz; Ruth Beverly (Rye, NY)
Assignee:	The Population Council, Inc. (New York, NY)
Application Number:	16/825,472
Patent Claims:	1. 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, a first channel within the ring body, a second channel within the ring body, a first core disposed within the first channel, a second core disposed within the second channel, 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; wherein the second core contains the 17.4 mg of ethinyl estradiol; wherein the first core is approximately 3.0 mm in diameter and approximately 11 mm in length and releases segesterone acetate alone; wherein the second core is approximately 3.0 mm and approximately 18 mm in length and releases both segesterone acetate and 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 each day 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 (b), 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. 2. The method of claim 1, further comprising: (e) removing the vaginal system from the female's vagina for more than two cumulative hours during any 21-day first period; and (f) reinserting the vaginal system into the vagina of the female of reproductive potential following the removal of the vaginal system from the female's vagina in step (d) and employing a secondary contraception product that does not comprise estrogen for seven days after reinserting the vaginal system. 3. The method of claim 1, wherein the first core contains approximately 50% segesterone acetate by mass. 4. The method of claim 1, wherein the second core contains approximately 40% segesterone acetate and approximately 12% ethinyl estradiol by mass. 5. The method of claim 1, further comprising storing the vaginal system at room temperature in a case when the vaginal system is removed from the vagina. 6. The method of claim 2, wherein removing the vaginal system from the female's vagina for more than two cumulative hours during the 21-day first period occurs in two or more instances on the same day, in two or more instances on consecutive or nonconsecutive days, or via a combination of occurrences on the same and different days. 7. The method of claim 2, wherein removing the vaginal system in step (d) comprises intentionally removing the system or expelling the system. 8. The method of claim 2, wherein the secondary contraception product that does not comprise estrogen is a male condom. 9. A method of providing birth control over the course of thirteen 28-day product-use cycles, 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, a first channel within the ring body, a second channel within the ring body, a first core disposed within the first channel, a second core disposed within the second channel, 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; wherein the first second core contains the 17.4 mg of ethinyl estradiol; wherein the first core is approximately 3.0 mm in diameter and approximately 11 mm in length and releases segesterone acetate alone; wherein the second core is approximately 3.0 mm and approximately 18 mm in length and releases both segesterone acetate and ethinyl estradiol; wherein the initial insertion on day 2, 3, 4, or 5 is the first day of a 21-day first period; wherein the vaginal system provides an average of approximately 0.15 mg/day of segesterone acetate and an average of approximately 0.013 mg/day of ethinyl estradiol in the 21-day first period as measured across the thirteen 28-day product-use cycles; (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 (b), wherein the 21-day first period and second period together comprise a product-use cycle; and (d) optionally 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. 10. The method of claim 9, further comprising: (e) removing the vaginal system from the female's vagina for more than two cumulative hours during any 21-day first period; and (f) reinserting the vaginal system into the vagina of the female of reproductive potential following the removal of the vaginal system from the female's vagina in step (e) and employing a secondary contraception product that does not comprise estrogen for seven days after reinserting the vaginal system. 11. The method of claim 9, wherein the first core contains approximately 50% segesterone acetate by mass. 12. The method of claim 9, wherein the second core contains approximately 40% segesterone acetate and approximately 12% ethinyl estradiol by mass. 13. The method of claim 10, wherein removing the vaginal system from the female's vagina for more than two cumulative hours comprises intentionally removing the vaginal system for more than two cumulative hours or unintentionally removing the vaginal system for more than two cumulative hours, or wherein removing the vaginal system for more than two cumulative hours comprises a combination of intentional and unintentional removals. 14. The method of claim 13, wherein unintentionally removing the vaginal system comprises expelling the vaginal system. 15. The method of claim 10, wherein the two cumulative hours out of the vagina are achieved via at least two instances wherein the vaginal system is removed from the vagina during the 21-day first period. 16. The method of claim 15, wherein the at least two instances take place on the same day or different days. 17. The method of claim 16, wherein the different days are consecutive different days or nonconsecutive different days.