TREATMENT OF EXCESSIVE MENSTRUAL BLOOD LOSS BY FEMININE SANITARY PRODUCTS MEDICATED WITH HEMOSTATIC AGENT

Abstract

A method, medicated feminine sanitary products and pharmaceutical compositions for reducing menstrual blood loss in a female are provided. The method includes administering a hemostatic agent on a medicated feminine sanitary product during menstrual bleeding, wherein the hemostatic agent is incorporated in the medicated feminine sanitary product as a pharmaceutically acceptable composition, wherein the hemostatic agent is -amino-caproic acid, wherein the feminine sanitary product includes an amount of -amino-caproic acid ranging from 100 mg to 500 mg.

Claims

1. A method for reducing menstrual blood loss in a female, comprising: administering a hemostatic agent on a medicated feminine sanitary product during menstrual bleeding, wherein the hemostatic agent is incorporated in the medicated feminine sanitary product as a pharmaceutically acceptable composition, wherein the hemostatic agent is -amino-caproic acid, wherein the feminine sanitary product includes an amount of -amino-caproic acid ranging from 100 mg to 500 mg.

2. The method of claim 1, wherein the medicated feminine sanitary product is a menstrual tampon.

3. The method of claim 1, wherein the medicated feminine sanitary product is any one of: a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, and a sanitary pad.

4. The method of claim 1, wherein the pharmaceutically acceptable composition includes any one of: a liquid solution, a capsule, a membrane, a drug-releasing strip, a tablet, powder, and gel.

5. The method of claim 1, wherein the amount of -amino-caproic acid in the medicated feminine sanitary product ranges from 200 mg to 400 mg.

6. The method of claim 1, wherein the female suffers from a medical condition comprising any one of: menorrhagia, idiopathic menorrhagia, cyclic heavy menstrual bleeding, dysfunctional uterine bleeding, and anemia.

7. A medicated feminine sanitary product, comprising: a hemostatic agent that reduces menstrual blood loss, wherein the hemostatic agent is incorporated in the medicated feminine sanitary product as a pharmaceutically acceptable composition, wherein the hemostatic agent is -amino-caproic acid, wherein the amount of -amino-caproic acid ranges from 100 mg to 500 mg.

8. The medicated feminine sanitary product of claim 7, wherein the amount of -amino-caproic acid ranges from 200 mg to 400 mg.

9. The medicated feminine sanitary product of claim 7, wherein the medicated feminine sanitary product is a menstrual tampon.

10. The medicated feminine sanitary product of claim 9, wherein the hemostatic agent is at least one of: uniformly distributed within a portion of the menstrual tampon, located in a part of the menstrual tampon selected from a center surface attached to the inner layer of the menstrual tampon, located in a part of the menstrual tampon selected from a side surface attached to the inner layer of the menstrual tampon, and located in a part of the menstrual tampon selected from an outer surface attached to the inner layer of the menstrual tampon.

11. The medicated feminine sanitary product of claim 7, wherein the medicated feminine sanitary product is any one of: a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, and a sanitary pad.

12. The medicated feminine sanitary product of claim 11, wherein the menstrual pad is designed to include any of a protuberance facing the vagina and a segment facing the vagina, wherein the hemostatic agent is incorporated in the menstrual pad as a pharmaceutically acceptable composition.

13. The medicated feminine sanitary product of claim 7, wherein the pharmaceutically acceptable composition includes any of: a liquid solution, a capsule, a membrane, a drug-releasing strip, a tablet, powder, and gel.

14. A pharmaceutical composition for intravaginal administration, comprising: a therapeutically effective amount of a hemostatic agent that reduces menstrual blood loss, wherein the pharmaceutical composition is included in a feminine sanitary product, wherein the hemostatic agent is -amino-caproic acid, wherein the pharmaceutical composition includes an amount of -amino-caproic acid ranging from 100 mg to 500 mg.

15. The pharmaceutical composition of claim 14, wherein the pharmaceutical composition is formulated as any of: an aqueous solution and a pharmaceutically acceptable solution of the active agent.

16. The pharmaceutical composition of claim 15, wherein the formulation is any of: liquid, foam, cream, ointment, and gel.

17. The pharmaceutical composition of claim 14, wherein the pharmaceutical composition is formulated as a tablet.

18. The pharmaceutical composition of claim 14, wherein the feminine sanitary product is a menstrual tampon.

19. The pharmaceutical composition of claim 14, wherein the feminine sanitary product is any of: a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, and a sanitary pad.

20. The pharmaceutical composition of claim 14, wherein the amount of -amino-caproic acid ranges from 200 mg to 400 mg.

Description

DETAILED DESCRIPTION

[0021] The embodiments disclosed herein are only examples of the many possible advantageous uses and implementations of the innovative teachings presented herein. In general, statements made in the specification of the present application do not necessarily limit any of the various claimed embodiments. Moreover, some statements may apply to some inventive features but not to others.

Definitions:

[0022] A feminine sanitary product is defined as an absorbent item worn by a woman during the menstrual period (for example, a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, or a menstrual tampon).

[0023] Menstrual flow is defined as encompassing menstrual blood and/or menstrual fluid.

[0024] A therapeutically effective amount of an antifibrinolytic or hemostatic agent is defined as the amount of a drug that results in a significant (preferably, at least 15%) reduction in menstrual blood loss when compared to the pre-treatment levels.

[0025] Certain disclosed embodiments provide for intravaginal delivery of a therapeutically effective amount of an antifibrinolytic or hemostatic agent for the reduction of menstrual blood loss and an improvement in related symptoms.

[0026] In a preferred embodiment, the antifibrinolytic or hemostatic agent is delivered on a feminine sanitary product. In one embodiment, the antifibrinolytic or hemostatic agent is administered from the onset of menstrual bleeding until the resolution of related symptoms or the end of the menstrual period. In another embodiment, the feminine sanitary product is selected from the group consisting of a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, and a menstrual tampon.

[0027] The drug formulation of embodiments of the disclosed technology is administered to females desiring to reduce menstrual blood loss at the time of menstrual bleeding, irrespective of the specific volume of menstrual blood loss (ranging from light discharge to extremely heavy bleeding).

[0028] In a preferred embodiment, the drug delivery device useful in the methods of the present invention is a feminine sanitary product (e.g., a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, or a menstrual tampon) with a design known in the art, which is designed to deliver active drug while absorbing menstrual flow (menstrual blood and/or menstrual fluid). In one embodiment, the active drug can be mixed throughout the feminine sanitary product. In another embodiment, the active drug can be distributed uniformly throughout the feminine sanitary product. In yet another embodiment, the active drug can be located in a part of the feminine sanitary product. In a further embodiment, the active drug can be located in a part of the feminine sanitary product selected from the center, one side, or outer surface attached to an inner layer (core).

[0029] The feminine sanitary product (e.g., a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, or a menstrual tampon) can utilize any other design providing absorption of menstrual flow (menstrual blood and/or menstrual fluid) along with drug release to the local affected tissues (e.g., uterine cavity).

[0030] In certain embodiments, the active drug can be incorporated into the feminine sanitary product as a pharmaceutically acceptable composition selected from the group consisting of a liquid solution, a capsule, a membrane, a drug-releasing strip, a tablet, powder, and gel. In another embodiment, the feminine sanitary product (e.g., a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, or a menstrual tampon) can be designed as a fluid-expandable menstrual tampon. In yet another embodiment, the feminine sanitary product can be designed as a menstrual pad (or sanitary napkin, or sanitary towel, or sanitary pad) with a protuberance projecting beyond the vaginal opening (introitus, vaginal orifice) into the vagina. In a further embodiment, the feminine sanitary product can be designed as a menstrual pad (or sanitary napkin, or sanitary towel, or sanitary pad) having a segment or region facing the vagina. In another embodiment, the feminine sanitary product can be designed as a menstrual pad (or sanitary napkin, or sanitary towel, or sanitary pad) penetrating into the vagina. In yet another embodiment, the feminine sanitary product can be designed as a menstrual pad (or sanitary napkin, or sanitary towel, or sanitary pad) with contact between a part of the pad and the vaginal walls.

[0031] In certain embodiments, the medicated menstrual tampon is inserted in the vagina in the same fashion as recommended for respective feminine sanitary products (menstrual tampons). In another embodiment, the medicated menstrual pad (or sanitary napkin, or sanitary towel, or sanitary pad) is utilized in the same fashion and regimen as recommended for respective feminine sanitary products, e.g., menstrual pads, sanitary napkins, sanitary towels, or sanitary pads.

[0032] The use of feminine sanitary products (e.g., a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, or a menstrual tampon) delivering drug directly to the affected tissues is expected to enhance the drug's efficacy in the reduction of the volume of menstrual blood loss and improvement in the related symptoms and a woman's quality of life; it may also result in a shorter duration of menstrual bleeding. The use of feminine sanitary products (e.g., a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, or a menstrual tampon) delivering drug directly to the affected tissues is also expected to significantly reduce the daily dose when compared to other routes of drug administration; this may result in a lower systemic drug circulation, possibly below detectable levels, and a lower incidence of drug-related adverse events.

[0033] In all embodiments, the active ingredient is from a class of drugs called antifibrinolytic agents or the hemostatic agents, including tranexamic acid, -amino-caproic acid, aprotinin, antipan, gabexate mesilate, pepstatin, leupeptin, chymostatin and others, or from a class of drugs called hemostatic agents and metabolites thereof. Also in all embodiments, a feminine sanitary product (e.g., a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, or a menstrual tampon) is medicated with an amount of active drug ranging from 50 mg to 1 g.

[0034] In a preferred embodiment, a feminine sanitary product (e.g., a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, or a menstrual tampon) is medicated with an amount of active drug ranging from 100 mg to 500 mg. In another embodiment, a feminine sanitary product (e.g., a menstrual pad, a maxi-pad, a mini-pad, a sanitary napkin, a sanitary towel, a sanitary pad, or a menstrual tampon) is medicated with amount of active drug ranging from 100 mg to 300 mg. In yet another embodiment, the active ingredient is tranexamic acid with the amount of active drug per medicated sanitary product ranging from 100 mg to 300 mg. In a further embodiment, the active ingredient is -amino-caproic acid with the amount of active drug per medicated sanitary product ranging from 200 mg to 400 mg. In another preferred embodiment, the active ingredient is aprotinin with the amount of active drug per medicated sanitary product ranging from 150 mg to 300 mg.

[0035] In certain embodiments, the drug formulation treats females with menstrual bleeding of less than 80 ml per menstrual cycle. In other embodiments, the drug formulation treats females with menstrual bleeding of more than 80 ml per menstrual cycle. In yet other embodiments, the drug formulation treats females clinically diagnosed with menorrhagia. In further embodiments, the drug formulation treats females clinically diagnosed with idiopathic menorrhagia. In other embodiments, the drug formulation treats females clinically diagnosed with cyclic heavy menstrual bleeding. In yet other embodiments, the drug formulation treats females clinically diagnosed with dysfunctional uterine bleeding. In further embodiments, the drug formulation treats females with no clinical diagnosis related to menorrhagia, idiopathic menorrhagia, cyclic heavy menstrual bleeding, or dysfunctional uterine bleeding, but who perceive their menstrual periods to be heavy. In other embodiments, the drug formulation treats females clinically diagnosed with anemia.

[0036] The present invention is also described and demonstrated by way of the following examples. However, the use of these and other examples anywhere in the specification is illustrative only and in no way limits the scope and meaning of the invention or of any exemplified term. Likewise, the invention is not limited to any particular preferred embodiments described here. Indeed, many modifications and variations of the invention may be apparent to those skilled in the art upon reading this specification, and such variations can be made without departing from the invention in spirit or in scope. The invention is therefore to be limited only by the terms of the appended claims along with the full scope of equivalents to which those claims are entitled.

[0037] Example 1: The feminine sanitary product serving as a drug delivery device is a menstrual tampon comprised of a conventional menstrual tampon base with pharmaceutical dosage component(s) attached to it. The latter are represented by 2-3 capsules. Each capsule contains a 10-15% aqueous solution of tranexamic acid. The total amount of drug per tampon ranges from 100 to 150 mg. Alternatively, pharmaceutically acceptable solution of -amino-caproic acid is used with the total amount of drug ranging from 200 mg to 400 mg. Alternatively, pharmaceutically acceptable solution of aprotinin is used with the total amount of drug ranging from 150 mg to 200 mg. Capsules are dissolved by the body's heat after insertion of the tampon. The material from which the capsule is constructed must be easily rupturable. Examples of such materials include gelatin and various synthetic resins known in the art.

[0038] The capsules are located on the entering end of tampon opposite to the conventional inserter device (cartridge) and/or withdrawal string of the tampon. Alternatively, they are located on opposite sides along the body of the tampon. The capsules have a mushroom shape with a stem portion at least partially embedded in the body of the tampon. The embedded portion is made from fluid-impermeable material. Alternatively, the capsules are placed on a surface of the body of the tampon and separated from that body by the patches made from fluid-impermeable material.

[0039] This embodiment is expected to control moderate-to-heavy menstrual bleeding. Method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual tampons.

[0040] Example 2: The feminine sanitary product serving as a drug delivery device is a menstrual tampon comprising of a conventional menstrual tampon base with pharmaceutical dosage component attached to it. The latter are represented by a vaginal tablet containing 100 to 150 mg of tranexamic acid. Alternatively, a vaginal tablet contains 200 mg to 300 mg of -amino-caproic acid. Alternatively, a vaginal tablet contains 150 mg to 200 mg of aprotinin. The tablet is slowly melted by the body's heat after insertion of the tampon.

[0041] The tablet is located on the entering end of tampon opposite to the conventional inserter device (cartridge) and/or withdrawal string of the tampon. The tablet is placed on a base partially embedded in the body of the tampon. The embedded portion is made from fluid-impermeable material. Alternatively, the tablet is placed on a surface of the body of the tampon and separated from that body by a patch made from fluid-impermeable material.

[0042] This embodiment is expected to control moderate-to-heavy menstrual bleeding. Method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual tampons.

[0043] Example 3: The feminine sanitary product serving as a drug delivery device is a menstrual tampon with a resilient foam corpus overwrapped with a medicament-impregnated covering. Detailed description of such tampon may be found in U.S. Pat. No. 3,902,493.

[0044] As is explained above, to ensure delivery of medications to the afflicted areas of the vagina, the suitable foams have a modulus of compression which allows the tampon to be reformed following insertion to conform to the irregularities of the vaginal wall and to achieve adequate vaginal contact (foam expandable by menstrual fluids is particularly suitable.)

[0045] In addition to the foam corpus, the tampon has a medicament-bearing hydrophobic non-woven overwrap permeable to vaginal fluids.

[0046] Per U.S. Pat. No. 3,902,493, the medicament composition is applied to a portion of the overwrap surface, thereby assuring that the absorptive properties of the tampon are not hindered and that the tampon performs adequately when worn during menstruation. The medicament composition represents an appropriate formulation of tranexamic acid. It is in the form of binding lubricant (as described in the referenced patent). Alternatively, it is in a form of 10% aqueous solution (100 mg of tranexamic acid in 1 mL of water), or a concentrated 25% solution (250 mg of tranexamic acid in 1 mL of water). Gel formulations of tranexamic acid (known in the art) may also be considered. The total amount of tranexamic acid per tampon ranges from 150 to 200 mg.

[0047] Alternatively, pharmaceutically acceptable solution of -amino-caproic acid is used with the total amount of drug ranging from 250 mg to 400 mg. Alternatively, pharmaceutically acceptable solution of aprotinin is used with the total amount of drug ranging from 200 mg to 250 mg.

[0048] Use of this embodiment is control of heavy menstrual bleeding. Method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual tampons.

[0049] Example 4: The feminine sanitary product serving as a drug delivery device is a menstrual tampon in combination with drug-containing reservoir. Detailed description of such tampon may be found in one of the embodiments of U.S. Pat. No. 4,318,405 which is herein incorporated by reference.

[0050] As is explained in the patent description, an important feature is the design of the tampon inserter permitting pre-wetting of the tampon prior to insertion into the vaginal cavity. In the referenced patent, the tampon and drug delivery device are submerged in a wetting solution, such as water, immediately prior to insertion. As a modification of this approach, the tampon inserter contains a 15% aqueous solution of tranexamic acid, with approximately 150 mg of drug available for delivery into the vaginal cavity. Alternatively, pharmaceutically acceptable solution of -amino-caproic acid is used with the total amount of drug ranging from 250 mg to 400 mg. Alternatively, pharmaceutically acceptable solution of aprotinin is used with the total amount of drug ranging from 150 mg to 200 mg. Pre-wetting creates a tampon impregnated with a therapeutically effective amount of tranexamic acid.

[0051] Use of this embodiment is control of moderate-to-heavy menstrual bleeding. Method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual tampons.

[0052] Example 5: The feminine sanitary product serving as a drug delivery device is a menstrual tampon adapted for carrying a medicament for selective expulsion during use. Detailed description of such tampon may be found in the U.S. Pat. No. 5,273,521 which is herein incorporated by reference. As it is explained in the patent description, a tampon has a tubular inserter, closed on one end, on which an elongated tampon body is mounted. A medicament is disposed in a longitudinal bore extending through the tampon body. A specially designed wand moves the medicament composition out of the bore into the vaginal cavity. After the medication is completely expelled, the wand is moved in the opposite direction until it is further withdrawn from the tampon body and, subsequently, from the vaginal cavity. (Another attractive option is to keep the bore within the tampon to provide continuous drug release into the vaginal cavity). The tampon's body is being comprised of an absorbent material having porous outer and inner surfaces. The string attached to the body of the tampon is necessary to remove the tampon after use.

[0053] The medicament composition represents an appropriate formulation of tranexamic acid. It is in form of 10% aqueous solution (100 mg of tranexamic acid in 1 mL of water), or concentrated 25% solution (250 mg of tranexamic acid in 1 mL of water). Gel formulations of tranexamic acid (known in the art) may also be considered. Alternatively, pharmaceutically acceptable solution of -amino-caproic acid is used with the total amount of drug ranging from 250 mg to 400 mg. Alternatively, pharmaceutically acceptable solution of aprotinin is used with the total amount of drug ranging from 200 mg to 250 mg.

[0054] Use of this embodiment is control of moderate-to-heavy menstrual bleeding. Method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual tampons.

[0055] Example 6: The feminine sanitary product serving as a drug delivery device is a menstrual tampon in combination with a drug delivery device attached to its body. The drug delivery device is represented by 2-4 strips positioned alongside the body of the tampon. Alternatively, these strips are positioned around the width of the body of the tampon. The strips are made from polymers known in the art (for example, polyethylene) and separated from the body of the tampon by liquid-impermeable material. An aqueous solution of tranexamic acid or any other appropriate formulation (such as an acetic acid-based solution of tranexamic acid, an ethanolic solution of tranexamic acid, or tranexamic acid powder) is deposited on the strips using manufacturing methods known in the art. Appropriate wetting agents, surfactants and excipients are added as necessary. The total amount of tranexamic acid per tampon ranges from 100 to 150 mg. Alternatively pharmaceutically acceptable solution of -amino-caproic acid is used with the total amount of drug ranging from 200 mg to 350 mg. Alternatively, pharmaceutically acceptable solution of aprotinin is used with the total amount of drug ranging from 150 mg to 200 mg.

[0056] Use of this embodiment is control of moderate-to-heavy menstrual bleeding. Method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual tampons.

[0057] Example 7: The drug delivery device is a menstrual pad with a protuberance designed to project beyond the vaginal opening (introitus, vaginal orifice) into the lower vagina. The protuberance represents a multi-dimensional, elongated body of fluid-impermeable material attached to the skin-facing region of the pad. It is approximately 2-2.5 inches long and 1-1.5 inches wide. The rest of the body of the pad is planar and elongated; it resembles the design of commercially available menstrual pads such as Kotex Maximum Protection or Always Maxi pads.

[0058] The protuberance, on its vaginal-facing aspect, is encapsulated within one or more rupturable membranes or capsules. Membranes or capsules containing tranexamic acid are ruptured as a result of a slight mechanical pressure when a menstrual pad is attached to the body (and the protuberance is projected into the vagina). Alternatively, they are dissolved by the body's heat. The membranes or capsules contain a 10% aqueous solution of tranexamic acid, with the total amount of drug being approximately 200 mg dilluted in 2 mL of water. Alternatively, pharmaceutically acceptable solution of -amino-caproic acid is used with the total amount of drug ranging from 250 mg to 400 mg. Alternatively, pharmaceutically acceptable solution of aprotinin is used with the total amount of drug ranging from 250 mg to 300 mg. The material of membrane or capsule must be easily rupturable. Examples of such materials include gelatin and various synthetic resins known in the art.

[0059] Use of this embodiment is control of light-to-moderate menstrual bleeding and occasional spotting. Method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual pads.

[0060] Example 8: The drug delivery device is a planar and elongated menstrual pad; it resembles the design of commercially available menstrual pads such as Kotex Maximum Protection or Always Maxi pads.

[0061] The pad, on its vaginal-facing aspect, is encapsulated within one or more rupturable membranes or capsules. Membranes or capsules containing tranexamic acid are ruptured as a result of a slight mechanical pressure when a menstrual pad is attached to the body. Alternatively, they are dissolved by the body's heat. The membranes or capsules contain a 10% aqueous solution of tranexamic acid, with the total amount of drug being approximately 200 mg diluted in 2 mL of water. Alternatively, pharmaceutically acceptable solution of -amino-caproic acid is used with the total amount of drug ranging from 250 mg to 400 mg. Alternatively, pharmaceutically acceptable solution of aprotinin is used with the total amount of drug ranging from 250 mg to 300 mg. The material of membrane or capsule must be easily rupturable. Examples of such materials include gelatin and various synthetic resins known in the art.

[0062] Use of this embodiment is control of light-to-moderate menstrual bleeding and occasional spotting. Method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual pads.

[0063] Example 9: The drug delivery device is a menstrual pad with a protuberance designed to project beyond vaginal opening (introitus, vaginal orifice). The protuberance represents a multi-dimensional, elongated body of fluid-impermeable material attached to the skin-facing region of the pad. It is approximately 2-2.5 inches long and 1-1.5 inches wide. The rest of the body of the pad is planar and elongated; it resembles the design of commercially available menstrual pads such as Kotex Maximum Protection or Always Maxis pads.

[0064] The protuberance, on its vaginal-facing aspect, contains 1-3 strips positioned alongside the body of the protuberance. Alternatively, these strips are positioned around the width of the body of the protuberance. The strips are made from polymers known in the art (for example, polyethylene) and separated from the body of the pad by liquid-impermeable material. Tranexamic acid aqueous solution or any other appropriate formulation (such as an acetic acid-based solution or an ethanolic solution of tranexamic acid) is deposited on the strips. Appropriate wetting agents or surfactants are added as necessary. The total amount of tranexamic acid per pad ranges from 100 to 150 mg. Alternatively, pharmaceutically acceptable solution of -amino-caproic acid is used with the total amount of drug ranging from 200 mg to 300 mg. Alternatively, pharmaceutically acceptable solution of aprotinin is used with the total amount of drug ranging from 200 mg to 250 mg.

[0065] Use of this embodiment is control of moderate-to-heavy menstrual bleeding. The method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual pads.

[0066] Example 10: The drug delivery device is a planar and elongated menstrual pad without a protuberance; it resembles the design of commercially available menstrual pads such as Kotex Maximum Protection or Always Maxis pads.

[0067] The pad, on its vaginal-facing aspect, contains 1-3 strips positioned alongside the body of the pad. The strips are made from polymers known in the art (for example, polyethylene) and separated from the body of the tampon by liquid-impermeable material. An aqueous solution of tranexamic acid, or any other appropriate formulation (such as an acetic acid-based solution or an ethanolic solution of tranexamic acid) is deposited on the strips. Appropriate wetting agents or surfactants are added as necessary. The total amount of tranexamic acid per pad ranges from 100 to 150 mg. Alternatively, pharmaceutically acceptable solution of -amino-caproic acid is used with the total amount of drug ranging from 200 mg to 300 mg. Alternatively, pharmaceutically acceptable solution of aprotinin is used with the total amount of drug ranging from 200 mg to 250 mg.

[0068] Use of this embodiment is control of moderate-to-heavy menstrual bleeding. Method and frequency of use of the described device are the same as routinely employed for non-medicated menstrual pads.

[0069] Example 11: The drug delivery device is a combination of a tampon and a menstrual pad. The possible design of such combination is described in the U.S. Pat. No. 6,059,763 which is herein incorporated by reference. The combination consists of a base pad having first and second length sides and first and second wings. The combination also includes a tampon extending substantially perpendicular to the base pad at its central portion. The tampon is positioned within the body opening.

[0070] The referenced patent describes a non-medicated feminine sanitary product. With the objective of the present invention in mindintravaginal administration of tranexamic acid to control menstrual bleedingthe non-medicated tampon is replaced with the devices described earlier. Particularly, the use of tampons as described in detail above is recommended. See related descriptions above for further information regarding tampon design, the dose of tranexamic acid and the use of the drug delivery device(s).

[0071] The present invention is not to be limited in scope by the specific embodiments described herein. Indeed, various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are intended to fall within the scope of the appended claims.

[0072] All patents, applications, publications, test methods, literature, and other materials cited herein are hereby incorporated by reference in their entirety as if physically present in this specification.

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