Method of providing birth control
AssigneeThe Population Council, Inc.
InventorsGeorge William Creasy, II, Ruth Beverly Merkatz
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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.
Claims17
A method of preventing pregnancy in a female of reproductive potential, the method comprising:
- (a) initially inserting into the vagina of the 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, 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;
- 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 from the female's vagina for more than two cumulative hours during the 21-day first period;
- (c) 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 (b) and employing a secondary contraception product that does not comprise estrogen for seven days after reinserting the vaginal system;
- (d) removing the vaginal system on the day following the end of the 21-day first period;
- (f) repeating steps (a) and (d) and optionally repeating steps (b) and (c), wherein steps (a) and (d) are each repeated up to 13 times including the initial insertion for a total of no more than 13 product-use cycles.
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;
- and wherein one of the first or second cores contains the 17.4 mg of 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;
- (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;
- the method further comprising:
- (e) removing the vaginal system from the female's vagina for more than two cumulative hours during at least one of the 21-day first periods in any of the thirteen product-use cycles;
- (f) reinserting the vaginal system into the female's vagina following the removal of the vaginal system from the female's vagina in step (e);
- and
- (g) employing a secondary contraception product that does not comprise estrogen for seven days after reinserting the vaginal system into the female's vagina.
A method of providing birth control, the method comprising:
- (a) inserting into the vagina of a female of reproductive potential 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;
- 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;
- (b) removing the vaginal system from the female's vagina for more than two cumulative hours during a 21-day first period;
- and
- (c) 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 (b) and employing a secondary contraception product that does not comprise estrogen for seven days after reinserting the vaginal system.
Dependencies are inferred from the claim text.