MXPA00005593A - Subcutaneous medroxyprogesterone acetate for treatment of menopause and endometriosis - Google Patents

Abstract

One aspect of the present invention is a method of human female menopause treatment which comprises subcutaneous administration of a menopausely effective amount of a hormonal replacement agent selected from the group consisting of a progestogen and a progestogen plus an estrogen. Another aspect of the present invention is treating endometriosis.

Description

SUBCUTANEOUS MEDROXYPROGESTERONE ACETATE FOR THE TREATMENT OF MENOPAUSE AND ENDOMETRIOSIS BACKGROUND OF THE INVENTION 1. Field of the Invention _ _____ The present invention is a subcutaneous method for administering a progestogen or a progestogen and an estrogen for contraceptive use of women or for the treatment of menopause. The present invention is also a method for the subcutaneous administration of a progesterone for the treatment of endometriosis. 2. Description of the Related Art U.S. Patent 3,377,364 (Example 9) shows acetate of medroxyproges terone. The 1996 Physicians Desk Reference (PDR), pages 2602-2604, states that DEPO-PROVERA, a sterile aqueous suspension of medro-_proges terone acetate for IM administration, produces a contraceptive effect for three months in women. After the three months of the contraceptive period, the woman has a menstrual period and is again fertile unless she is given another IM injection before her period.

The J. Reprod. Férti l. , 15, 209-14 (1968) presents a clinical study of medroxyprogesterone acetate (25 mg) and estradiol cypionate (5 mg) by monthly IM injection for female contraception in 104 women over a period of four to 15 months without pregnancies After each IM injection there is a contraceptive effect for a period of time of one month after which the woman has a menstrual period. Con trapt on, 56, 353-359 (1997) also discusses a clinical study of medroxyprogesterone acetate (25 mg) and estradiol cypionate. (5 mg) by monthly IM injection for contraception in women. These two methods work well to provide contraception for women in their periods of ovulation who want to have sex without becoming pregnant. The main problem is that in both cases the injection is IM and the IM injections should not be administered by the patient herself, rather they should be administered by a properly trained health care professional. The method of the present invention does not depend on the IM administration, although it depends a lot on the subcutaneous administration that can be performed by the patient. In the treatment of menopause or the symptoms of menopause, the normal therapy is estrogen or estrogen plus progesterone administered orally on a daily basis. U.S. Patent 4,826,831 discloses a method of hormone treatment of menopausal women using any progesterone, including medroxyprogesterone acetate, and estrogen by oral or intramuscular injection, as well as by an implantable composition. Endometriosis is the presence of a growth of endometrial tissue on the outside of the internal uterine lining. It is known to those skilled in the art that proges terones can be administered orally to treat this condition. The present invention does not use oral administration.

BRIEF DESCRIPTION OF THE INVENTION A method for the treatment of human menopause is disclosed comprising the subcutaneous administration of a menopausally effective amount of a hormone replacement agent selected from the group consisting of a progestogen and a progestogen plus an estrogen. A method for treating endo-thrombosis in a woman in need of this treatment is also disclosed, comprising the subcutaneous administration of an endometrially effective amount of a progesterone.

DETAILED DESCRIPTION OF THE INVENTION The present invention is a method for human female contraception comprising the subcutaneous administration of a contraceptively effective amount selected from the group consisting of a progestogen and a progestogen plus a trogen. The method of the present invention can be practiced by the patient herself by administering the subcutaneous injection herself. To provide contraception, the patient must have the instruction of a trained health care professional on how to administer the subcutaneous injection of progestogen or progestogen plus estrogen. The patient is then injected subcutaneously with a contraceptively effective amount as instructed either approximately once a month or approximately every three months or approximately every six months. The word "approximately" is used because some months have 30 days while others have 31 days. . Also, it is not critical if the woman has a variation of one to three days from the exact time to administer the subcutaneous injection due to any reason. There are two ways of practicing the claimed invention. These are either the administration of a progestogen alone or the combination of a progestogen with an estrogen. When the progestogen is administered alone, it is administered either once a month or until approximately every six months or any interval between these times, depending on the dose. When the patient uses the three or six month methods, she will not have a menstrual period during that time. When the progesterone method is used alone, it is preferred that the woman administer the subcutaneous injection either approximately every three or approximately every six months. At the end of a month, three months or six months time period, normal fertility returns unless the patient uses another injection or some other form of fertility control. Alternatively, the method of the present invention can be practiced by administering a combination of a progestogen plus an estrogen once a month. When this method is used, the woman will have a menstrual period every month. At the end of each monthly time period, normal fertility returns unless the patient uses another injection or some other form of fertility control. The pharmaceutical formulations necessary to practice the present invention are known. U.S. Patent 4,038,389 discloses a parenteral formulation of 200 to 600 mg / ml of medroxyprogesterone acetate. The 1996 Physicians Desk Reference (PDR), pages 2602-2604, discloses a sterile aqueous suspension of medroxyprogesterone acetate (DEPO-PROVERA) to deposit IM administration for female contraception containing 150 mg of medroxyprogesterone acetate / ml. The parenteral formulation can be administered once every month or every 13 weeks (3 months) or every 26 weeks (6 months). After the contraceptive period, the woman has a menstrual period unless another IM injection has been administered before her period. The woman may be given a series of IM injections of edroxyprogesterone acetate to provide contraception on a continuous basis. The J. R ep rod. Fertility , 15, 209-14 (1968) discloses a formulation of medroxyprogesterone acetate (25 mg) and estradiol cypionate (5 mg) that is used in a clinical study using the monthly IM injection for female contraception. See also Con tra ti ti on, 49, 293-301 (1994) in 296 and With t ra cep ti on, 56, 353-359 (1997) at 353. It is preferred that progesterone is selected from the group consisting of medroxyprogesterone acetate, progesterone, norethindrone, desogestrel and levo-norges t rei, is preferred in greater as the progestogen is medroxyprogesterone acetate. It is preferred that the estrogen be selected from the group consisting of ethinyl estradiol, estradiol cypionate and estradiol valerate; it is more preferred that the estrogen be estradiol cypionate. It is preferred that the contraceptive agent be medroxyprogesterone acetate or medroxyprogesterone acetate plus estradiol cypionate.

When the contraceptive method of the present invention is practiced by using a progestogen alone, it is preferred that the progestogen be in a form "deposited as is well known to those skilled in the art." It is preferred that the amount contraceptively effective for one month for the Medroxyprogesterone acetate is from about 10 mg to about 50 mg / female, for progesterone from about 25 mg to about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / female, to desogestrel from about 1 mg to about 4 mg / woman, for levo-norges trel from approximately 0.5 mg to approximately 2 mg / woman, for three months for medroxyprogesterone acetate it is from approximately 50 mg to approximately 200 mg / woman, for progesterone from approximately 25 mg to approximately 200 mg / woman, for norethindrone from approximately 5 mg to approximately 50 mg / woman, for desogestrel of approximately 1 m about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / female and for six months for medroxyprogesterone acetate is from about 100 mg to about 500 mg / female, for progesterone from about 25 mg to about 200 mg / woman, for norethindrone from approximately 5 mg to approximately 50 mg / woman, for desogestrel from approximately 1 mg to approximately 4 mg / woman, for levo-norgestrel from approximately 0.5 mg to approximately 2 mg / woman. When the progestogen is medroxyprogesterone acetate, it is preferred that the dose for one, three and six months be from about 20 mg to about 30 mg / female, from about 75 mg to about 175 mg / female and from about 150 mg to about 300 mg / woman Alternatively and operable although less preferred, at three months the dose of medroxyprogesterone acetate is from about 100 mg to about 200 mg / woman; at six months the dose of medroxyprogesterone acetate is from approximately 200 mg to approximately 500 mg / woman. Within this alternative range, it is preferred that the dose of medroxyprogesterone erona for three months be from about 125 mg to about 175 mg / woman and for six months from about 250 mg to about 300 mg / woman. When the contraceptive method of the present invention is practiced by using a progestogen plus an estrogen once a month, the progestogen and the estrogen should be in a formulation suitable for subcutaneous administration as is known to those skilled in the art. It is preferred that the contraceptively effective amount be: for medroxyprogesterone acetate from about 10 mg to about 50 mg / female, for progesterone from approximately 25 mg to approximately 200 mg / woman, for norethindrone from approximately 5 mg to approximately 50 mg / woman, for desogestrel from approximately 1 mg to approximately 4 mg / woman, for levo-norges trel of approximately 0.5 mg a approximately 2 mg / woman. and the contraceptively effective amount of estrogen is: for estradiol cypionate from about 2.5 mg to about 20 mg / female, ethinyl estradiol from about 0.5 mg to about 3 mg / female, estradiol valerate of about 2. 5 mg to approximately 20 mg / woman. It is preferred that the contraceptively effective amount of medroxyprogesterone acetate be from about 20 mg to about 30 mg / female and the contraceptively effective amount of estradiol cypionate be from about 3 to about 10 mg / mo. The present invention is a method for the treatment of human menopause comprising the subcutaneous administration of a menopausally effective amount of a hormone replacement agent selected from the group consisting of a progestogen and a progestogen plus an estrogen. The method of the present invention can be practiced by the patient herself by administering the subcutaneous injection herself. To provide treatment for menopause, the patient should be instructed by a trained health care professional on how to administer the subcutaneous injection of progestogen or progestogen plus estrogen. The patient is then injected subcutaneously with a menopausally effective amount as instructed either approximately once a month or approximately every three months or approximately every six months. The word "approximately" is used because some months have 30 days while others have 31 days. In addition, it is not critical if the woman has a variation of one to three days at the exact time to administer the subcutaneous injection due to any reason. There are two ways of practicing the claimed invention. These are either the administration of a progestogen alone or the combination of a progestogen with an estrogen. When the progestogen is administered alone, it is administered either once a month, or approximately every three months or approximately every six months. When the patient uses the three or six month methods she will not have a menstrual period during that time. When the progestogen method is used alone, it is preferred that the woman administer the subcutaneous injection either approximately every three or approximately every six months. Alternatively, the method of the present invention can be practiced by administering a combination of progestogen plus an estrogen once a month. When this method is used, the woman will have a menstrual period every month. The pharmaceutical formulations necessary to practice the present invention were discussed in the foregoing and are well known to those skilled in the art. It is preferred that the progestogen be selected from the group consisting of medroxyprogesterone acetate, progesterone, norethindrone, desogestrel and levo-norgestrel; It is preferred that the progestogen be medroxyprogesterone acetate. It is preferred that the estrogen be selected from the group consisting of ethinyl estradiol, estradiol cypionate and estradiol valerate; it is more preferred that the estrogen be estradiol cypionate. It is preferred that the hormone replacement agent be medroxyprogesterone acetate or medroxyprogesterone acetate plus estradiol cypionate. When the menopausal treatment of the present invention is practiced by using a progestogen alone, it is preferred that the progestogen be in a deposited form as is well known to those skilled in the art. It is preferred that the menopausally effective amount for one month for medroxyprogesterone acetate be from about 10 mg to about 50 mg / female, for progesterone from about 25 mg to about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / woman, for desogestrel from approximately 1 mg to approximately 4 mg / woman, for levo-norgestrel from approximately 0.5 mg to approximately 2 mg / woman; for three months for medroxyprogesterone acetate is from approximately 50 mg to approximately 200 mg / woman, for progesterone from approximately 25 mg to approximately 200 mg / woman, for norethindrone from approximately 5 mg to approximately 50 mg / woman, for desogestrel from approximately 1 mg to approximately 4 mg / woman, for levo-norgestrel from approximately 0.5 mg to approximately 2 mg / woman and for six months for medroxyprogesterone acetate is from approximately 100 mg to approximately 500 mg / woman, for progesterone from approximately 25 mg to approximately 200 mg / woman, for norethindrone from approximately 5 mg to approximately 50 mg / woman, for desogestrel from approximately 1 mg to approximately 4 mg / woman, for levo-norgestrel from approximately 0.5 mg to approximately 2 mg /woman. When the progestogen is medroxyprogesterone acetate, it is preferred that the dose for one, three and six months is from about 20 mg to about 30 mg / female, from about 75 mg to about 175 mg / female and from about 150 mg to about 300 mg / woman. Alternatively and operable but less preferred, at three months the dose of medroxyprogesterone acetate is from about 100 mg to about 200 mg / female; at six months the dose of medroxyprogesterone acetate is from about 200 mg to about 500 mg / woman Within this alternative range, it is preferred that the dose of medroxyprogesterone acetate for three months be from about 125 mg to about 175 mg / woman and for six months from approximately 250 mg to approximately 300 mg / woman.When practicing the menopause treatment of the present invention by using a progestogen plus an estrogen once a month, the progestogen and the estrogen should be in a Formulation suitable for subcutaneous administration as is known to those skilled in the art It is preferred that the menopausically effective amount be: for medroxyprogesterone acetate from about 10 mg to about 50 mg / female, for progesterone from about 25 mg to about 200 mg / woman, for norethindrone from approximately 5 mg to approximately 50 mg / woman, for desogestrel approximately 1 mg to approximately 4 mg / woman, for levo-norges trel of approximately 0. 5 mg to approximately 2 mg / woman. and the menopausally effective amount of estrogen is: for estradiol cypionate from about 2.5 mg to about 20 mg / female, ethinyl estradiol from about 0.5 mg to about 3 mg / female, estradiol valerate from about 2.5 mg to about 20 mg / female . It is preferred that the menopausally effective amount of medroxyprogesterone acetate is from about 20 mg to about 30 mg / female and the menopausally effective amount of estradiol cypionate is from about 3 to about 10 mg / female. Another aspect of the present invention is a method for treating endometriosis in a woman in need of this treatment comprising the subcutaneous administration of an endometrially effective amount of a progestogen.

The method of the present invention can be practiced by the patient herself by administering the subcutaneous injection herself. To provide effective treatment, the patient should be instructed by a trained health care professional on how to administer the subcutaneous progestogen injection. The patient is then injected subcutaneously with an endometrially effective amount as instructed either approximately once a month or approximately every three months or approximately every six months. The word "approximately" is used because some months have 30 days while others have 31 days. In addition, it is not critical if the woman has a variation of one to three days from the exact time to administer the subcutaneous injection due to any reason. When the progestogen is administered, it is administered either once in a month, or approximately every three months or approximately every six months. When the patient uses the three or six month methods, she will not have a menstrual period during that time. It is preferred that the woman administer the subcutaneous injection either approximately every three or approximately every six months. The pharmaceutical formulations necessary to "practice the present invention" were discussed in the foregoing and are well known to those skilled in the art. It is preferred that the progestogen be selected from the group consisting of medroxyprogesterone acetate, progesterone, norethindrone, desogestrel and levo-norgestrel; It is preferred that the progestogen be medroxyprogesterone acetate. When practicing the endometriosis treatment of the present invention, it is preferred that the progestogen be in a deposited form as is well known to those skilled in the art. It is preferred that the endometrially effective amount for one month for medroxyprogesterone acetate be from about 10 mg to about 50 mg / female, for proges terone from about 25 mg to about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / woman, for desogestrel from approximately 1 mg to approximately 4 mg / woman, for levo-norgestrel from approximately 0.5 mg to approximately 2 mg / woman; for three months for medroxyprogesterone acetate is from approximately 50 mg to approximately 200 mg / woman, for progesterone from approximately 25 mg to approximately 200 mg / woman, for noxetindrona from approximately 5 mg to approximately 50 mg / woman, for desogestrel of approximately 1 mg at about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / female and for six months for medroxyprogesterone acetate is from about 100 mg to about 500 mg / female, for progesterone from about 25 mg to about 200 mg / woman, for norethindrone from approximately 5 mg to approximately 50 mg / woman, for desogestrel from approximately 1 mg to approximately 4 mg / woman, for levo-norgestrel from approximately 0.5 mg to approximately 2 mg / woman. When the progestogen is medroxyprogesterone acetate, it is preferred that the dose for one, three and six months is from about 20 mg to about 30 mg / female, from about 75 mg to about 175 mg / female and from about 150 mg to about 300 mg / woman Alternatively and operable although less preferred, at three months the dose of medroxyprogesterone acetate is from about 100 mg to about 200 mg / female; at six months the dose of medroxyprogesterone acetate is from approximately 200 mg to approximately 500 mg / woman. Within this alternative range, it is preferred that the dose of medroxyprogesterone acetate for three months be from about 125 mg to about 175 mg / female and for six months from about 250 mg to about 300 mg / female. The dose and frequency of exact administration of the progestogen or progestogen plus estrogen for the treatment of contraception, in menopause or endometriosis depends on the age, weight, general physical condition of the particular patient, another medication of the person may be administered as is well known to those skilled in the art and can be more accurately determined by measuring the blood level or concentration of progestogen or progestogen and estrogen in the patient's blood and / or the patient's response to the particular condition to be treated. .

DEFINITIONS The following definitions and explanations are for the terms co or are used throughout this entire document that include both the specification and the claims. Medroxyprogesterone acetate refers to 17-acetate-17a-hydroxy-6-met ilpregn- -en-3, -dione. IM refers to intramuscular injection. Menopause refers to premenopause, menopause and postmenopause and includes the same.

EXAMPLES Without further elaboration, it is believed that one skilled in the art can, using the above description, practice the present invention to its fullest extent. The following detailed examples describe the manner of preparing the various compounds and / or performing the various proponents of the invention and should be interpreted simply as illustrative and not as limitations of the foregoing description in any way that this could be. Those skilled in the art will readily recognize appropriate variations from the procedures for both the reactants and the reaction conditions and techniques. EXAMPLE 1 23-Year-Old Woman-One Month of Progestogen A 23-year-old woman weighing 60 kg you want to have sex on a regular basis shows you how to give yourself a subcutaneous injection by your doctor. She injected 0.2 ml of about 100 mg / ml of an aqueous suspension of subcutaneous medroxyprogesterone acetate as instructed, on the third day of her menstrual period. She has sex twice a week with a fertile man and does not get pregnant. EXAMPLE 2 37-Year-Old Woman-Three Months of Progestogen A 37-year-old woman weighing 78 kg who wishes to have sex on a regular basis is shown how to administer a subcutaneous injection by the nurse: your doctor. She injected 1.0 ml of about 125 mg / ml of an aqueous suspension of subcutaneous medroxyprogesterone acetate as instructed, on the second day of her menstrual period. She has sex three times in a week with a fertile man. and do not get pregnant.

EXAMPLE 3 21-Year-Old Woman-Six Months of Progestogen A 21-year-old woman weighing 67 kg who wishes to have sex on a regular basis is shown how to administer a subcutaneous injection by her gynecologist. She injected 1.0 ml of about 250 mg / ml of an aqueous suspension of subcutaneous medroxyprogesterone acetate as instructed, on the third day of her menstrual period. She has sex for six months with an average of three and a half times in a week with a fertile man and does not become pregnant. EXAMPLE 4 40-Year-Old Woman-Progestogen plus Estrogen A 40-year-old woman weighing 71 kg who wishes to have sex on a regular basis is shown how to administer a subcutaneous injection by her doctor's nurse. She injects 0.5 ml of an aqueous suspension containing 20 mg of medroxyprogesterone acetate and 7.0 mg of estradiol cypionate as instructed, on the second day of her menstrual period. She has sex three times in a week with a fertile man and does not get pregnant.

Claims (39)

1. CLAIMS 1. A method for the treatment of human menopause comprising the subcutaneous administration of a menopausally effective amount of a hormone replacement agent selected from the group consisting of a progestogen and a progestogen plus an estrogen.
2. 2. A method for the treatment of human menopause, according to claim 1, wherein the progestogen is selected from the group consisting of medroxyprogesterone acetate, progesterone, norethindrone, desogestrel and levo-norgestrel.
3. 3. A method for the treatment of human menopause according to claim 2, wherein the progestogen is acetate of medroxyproges erona.
4. 4. A method for the treatment of human menopause according to claim 1, wherein the estrogen is selected from the group consisting of ethinyl estradiol, estradiol cypionate and estradiol valerate.
5. 5. A method for the treatment of human menopause according to claim 4, wherein the estrogen is estradiol cypionate.
6. 6. A method for the treatment of human menopause according to claim 1, wherein the hormone replacement agent is medroxyprogesterone acetate.
7. 7. A method for the treatment of human menopause according to claim 1, wherein the hormone replacement is medroxyprogesterone acetate plus estradiol cypionate.
8. 8. A method for the treatment of human menopause according to claim 1, wherein when the menopausally effective amount of progestogen is administered once a month, the menopausally effective amount is: for medroxyprogesterone acetate from about 10 mg to about 50 mg / female , for progesterone from about 25 mg to about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / female, for desogestrel from about 1 mg to about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / woman. - -
9. 9. A method for the treatment of human menopause according to claim 8, wherein the menopausally effective amount of medroxyprogesterone acetate is from about 20 mg to about 30 mg / female.
10. 10. A method for the treatment of human menopause according to claim 1, wherein when the menopausally effective amount of progesterone is administered every three months, the menopausally effective amount is: for medroxyprogesterone acetate from about 50 mg to about 200 mg / female, for progesterone from about 25 mg to about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / female, for desogestrel from about 1 mg to about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / woman
11. 11. A method for the treatment of human menopause according to claim 10, wherein the menopausally effective amount of medroxyprogesterone acetate is from about 75 mg to about 175 mg / female.
12. 12. A method for the treatment of human menopause according to claim 1, wherein when the menopausally effective amount of progestogen is administered every three months, the menopausally effective amount is: for medroxyprogesterone acetate from about 100 mg to about 200 mg / female, for progesterone from about 25 mg to about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / female, for desogestrel from about 1 mg to about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / woman
13. 13. A method for the treatment of human menopause according to claim 12, wherein the menopausally effective amount of medroxyprogesterone acetate is from about 125 mg to about 175 mg / female.
14. 14. A method for the treatment of human menopause according to claim 1, wherein when the menopausally effective amount of progestogen is administered every six months, the menopausally effective amount is: for medroxyprogesterone acetate from about 100 mg to about 500 mg / female, for progesterone from about 25 mg to about 200 mg / female, for norethindrone from approximately 5 mg to approximately 50 mg / woman, for desogestrel from approximately 1 mg to approximately 4 mg / woman, for levo-norgestrel from approximately 0.5 mg to approximately 2 mg / woman.
15. 15. A method for the treatment of human menopause according to claim 14, wherein the menopausally effective amount of medroxyprogesterone acetate is from about 150 mg to about 300 mg / female.
16. 16. A method for the treatment of human menopause according to claim 1, wherein when the menopausally effective amount of progestogen is administered every six months, the menopausally effective amount is: for medroxyprogesterone acetate of about 200 mg to about 500 mg / woman, for progesterone from about 25 mg to about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / female, for desogestrel from about 1 mg to about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / woman
17. 17. A method for the treatment of human menopause according to claim 16, wherein the menopausally effective amount of medroxyprogesterone acetate is from about 250 mg to about 300 mg / female.
18. 18. A method for the treatment of human menopause according to claim 1, wherein both progestogen and estrogen are administered once a month, the menopausally effective amount of progestogen is: for medroxyprogesterone acetate from about 10 mg to about 50 mg / female, for progesterone from about 25 mg to about 200 mg / female, * for norethindrone from about 5 mg to about 50 mg / female, for desogestrel from about 1 mg to about 4 mg / female, for levo-norgestrel from about 0.5 mg to approximately 2 mg / woman. and the menopausally effective amount of estrogen is: for estradiol cypionate from about 2.5 mg to about 20 mg / female, ethinyl estradiol from about 0.5 mg to about 3 mg / female, estradiol valerate from about 2.5 mg to about 20 mg / female .
19. 19. A method for the treatment of human menopause according to claim 18, wherein the menopausally effective amount of medroxyprogesterone terone acetate is from about 20 mg to about 30 mg / female and the menopausally effective amount of estradiol cypionate is about 3 mg. to approximately 10 mg / woman.
20. 20. A method for the treatment of human menopause according to claim 1, wherein the menopausally effective amount of progestogen is administered either approximately every 3 or approximately every 6 months.
21. 21. A method for the treatment of human menopause according to claim 1, wherein the treatment for menopause is for premenopause.
22. 22. A method for the treatment of human menopause according to claim 1, wherein the treatment for menopause is for menop-ausia.
23. 23. A method for the treatment of human menopause according to claim 1, wherein the treatment for menopause is for postmenopause.
24. 24. A method for the treatment of human menopause according to claim 1, wherein the subcutaneous administration of the menopausally effective amount of a hormone replacement agent is by self-administration:
25. 25. A method for treating endometriosis in a woman in need of such treatment, comprising the subcutaneous administration of an endometrially effective amount of a progestogen.
26. 26. A method for treating endometriosis in a woman according to claim 25, wherein the < Progestogen is selected from the group consisting of medroxyprogesterone acetate, progesterone, norethindrone, desogestrel and levo-norgestrel.
27. 27. A method for treating endometriosis in a woman according to claim 26, wherein the progestogen is medroxyprogesterone acetate.
28. 28. A method for treating endometriosis in a woman according to claim 25, wherein the endotrially effective amount of progestogen is administered once a month and is for medroxyprogesterone acetate from about 10 mg to about 50 mg / female, for about 25 progesterone. mg at about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / female, for desogestrel from about 1 mg to about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / female.
29. 29. A method for treating endometriosis in a woman according to claim 28, wherein the endometrially effective amount of medroxyprogesterone acetate is from about 20 mg to about 30 mg / female.
30. 30. A method for treating endometriosis in a woman according to claim 25, wherein the endometrially effective amount of progestogen is administered every three months and is: for medroxyprogesterone acetate from about 50 mg to about 200 mg / female, for progesterone of about 25 mg at about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / female, for desogestrel from about 1 mg to about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / female.
31. 31. A method for treating endometriosis in a woman according to claim 30, wherein the endometrially effective amount of medroxyprogesterone acetate is from about 75 mg to about 175 mg / female.
32. 32. A method for treating endometriosis in a woman according to claim 25, wherein the endometrially effective amount of progestogen is administered every three months and is: for medroxyprogesterone acetate of about 100 mg to about 200 mg / female, for progesterone of about 25 mg at about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / female, for desogestrel from about 1 mg to about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / female.
33. 33. A method for treating endometriosis in a woman according to claim 32, wherein the endometrially effective amount of medroxyprogesterone acetate is from about 125 mg to about 175 mg / female.
34. 34. A method for treating endometriosis in a woman according to claim 25, wherein the endometrially effective amount of progestogen is administered every six months and is: for medroxyprogesterone acetate from about 100 mg to about 500 mg / m, for progesterone of about 25 mg at approximately 200 mg / woman, for norethindrone from approximately 5 mg to approximately 50 mg / woman, for desogestrel from approximately 1 mg to approximately 4 mg / woman, for levo-norgestrel from approximately 0.5 mg to approximately 2 mg / woman.
35. 35. A method for treating endometriosis in a woman according to claim 34, wherein the endometrially effective amount of medroxyprogesterone acetate is from about 150 mg to about 300 mg / female.
36. 36. A method for treating endometriosis in a woman according to claim 25, wherein the endometrially effective amount of progestogen is administered every six months and is: for medroxyprogesterone acetate of about 200 mg to about 500 mg / female, for progesterone of about 25 mg at about 200 mg / female, for norethindrone from about 5 mg to about 50 mg / female, for desogestrel from about 1 mg to about 4 mg / female, for levo-norgestrel from about 0.5 mg to about 2 mg / female.
37. 37. A method to treat endometriosis in a. The female according to claim 36, wherein the endometrially effective amount of medrsxiprogesterone acetate is from about 250 mg to about 300 mg / female.
38. 38. A method for treating endometriosis in a woman according to claim 25, wherein the endometrially effective amount of progestogen is administered either approximately every 3 or approximately every 6 months.
39. 39. A method for treating endometriosis in a woman according to claim 25, wherein the endometrially effective amount of progestogen is administered by self-administration.