# US 10,765,628 B2 · Method of providing birth control

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- Number: US 10,765,628 B2
- Document ID: US10765628B2
- Status: Granted
- Kind: B2
- Application number: 16/825,522
- Filed: 2020-03-20
- Published: 2020-08-06
- Granted: 2020-09-08
- Earliest claimed: 2019-02-01
- Assignees: The Population Council, Inc.
- Applicants: The Population Council, Inc.
- Inventors: George William Creasy, II; Ruth Beverly Merkatz
- Web page: https://patentgrep.com/patent/US10765628B2

## CPC

- A61K 9/0036: {Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms}
- A61F 6/04: Condoms, sheaths or the like {, e.g. combined with devices protecting against contagion}
- A61F 6/065: {Condom-like devices worn by females}
- A61K 9/0092: {Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes}
- A61K 31/565: not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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.

## Claims

### Claim 1

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.

### Claim 2 (depends on 1)

The method of claim 1, further comprising storing the vaginal system at room temperature when the vaginal system is removed from the vagina.

### Claim 3 (depends on 1)

The method of claim 1, 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.

### Claim 4 (depends on 1)

The method of claim 1, wherein removing the vaginal system in step (b) comprises intentionally removing the system or expelling the system.

### Claim 5 (depends on 1)

The method of claim 1, wherein the secondary contraception product that does not comprise estrogen is a male condom.

### Claim 6

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.

### Claim 7 (depends on 6)

The method of claim 6, 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.

### Claim 8 (depends on 7)

The method of claim 7, wherein unintentionally removing the vaginal system comprises expelling the vaginal system.

### Claim 9 (depends on 6)

The method of claim 6, 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.

### Claim 10 (depends on 9)

The method of claim 9, wherein the at least two instances take place on the same day or different days.

### Claim 11 (depends on 10)

The method of claim 10, wherein the different days are consecutive different days or nonconsecutive different days.

### Claim 12

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.

### Claim 13 (depends on 12)

The method of claim 12, 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.

### Claim 14 (depends on 13)

The method of claim 13, wherein unintentionally removing the vaginal system comprises expelling the vaginal system.

### Claim 15 (depends on 12)

The method of claim 12, 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.

### Claim 16 (depends on 15)

The method of claim 15, wherein the at least two instances take place on the same day or different days.

### Claim 17 (depends on 16)

The method of claim 16, wherein the different days are consecutive different days or nonconsecutive different days.