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1. WO2021064132 - TRAITEMENT DU SYNDROME DE LA MÉNOPAUSE ET/OU DES SYMPTÔMES ASSOCIÉS À LA MÉNOPAUSE

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

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Claims

1. A composition comprising:

- hyaluronic acid or a pharmaceutically acceptable salt thereof, and

- one or more proanthocyanidins;

for use in a method of treating a perimenopausal, menopausal or postmenopausal female subject in need thereof.

2. The composition for use according to claim 1 , wherein the method comprises the prevention, suppression or alleviation of at least one symptom associated with menopause.

3. Composition for use according to claim 1 or 2, wherein the symptom associated with menopause is selected from the group consisting of vasomotor symptoms, such as hot flushes, palpitations and night sweating; symptoms associated with vulvar and vaginal atrophy, such as loss of libido, vaginal pain associated with sexual activity; bleeding associated with sexual activity; dyspareunia, dysuria, vaginal infections, pruritus; dryness, irritation, itching, and/or burning in and around the vaginal area; symptoms associated with brain-nervous system changes, such as nervousness, insomnia, fatigue, depression, hypomnesis, loss of concentration and dizziness; symptoms resulting from musculoskeletal changes, such as myalgia, arthralgia and back pain; symptoms caused by urinogenital changes such as urinary frequency or urinary incontinence; emotional disturbances, such as irritability, nervousness, feelings of sadness, lack of motivation, anxiety, aggressiveness, difficulty concentrating, fatigue, mood changes and tension.

4. The composition for use according to any one of the preceding claims, wherein the number average molecular weight of hyaluronic acid or the pharmaceutically acceptable salt thereof is within the range of 0.01-10 MDa, preferably 0.1-5 MDa, preferably 1-1.5 MDa.

5. The composition for use according to any of the preceding claims, wherein the ratio of hyaluronic acid to proanthocyanidins is within the range of 10:1 to 1 :10, preferably within the range of 5:1 to 1 :5, preferably within the range of 5:1 to 1 :2, most preferably within the range of 3: 1 to 1 :1.

6. The composition for use according to any of the preceding claims, wherein the one or more proanthocyanidins are present in the form of Pinus pinaster bark extract.

7. The composition for use according to any of the preceding claims, said composition further comprising Nw-methylserotonin, preferably in the form of Cimicifuga racemosa root extract.

8. The composition for use according to any of the preceding claims, said composition further comprising one or two ingredients selected from vitamin C and a ginkgolide, preferably in the form of powdered Ginkgo biloba leaf.

9. The composition for use according to any of claims 1 -7, said composition further comprising one, two or three ingredients selected from valerenic acid, preferably in the form of Valeriana officinalis root extract; apigenin, preferably in the form of Matricaria recutita flower extract; and a magnesium source, preferably in the form of trimagnesium citrate.

10. The composition for use according to any of claims 1-7, wherein the method of treating the female subject, comprises

a) the administration of a first composition, preferably in unit dosage form, comprising:

- hyaluronic acid or a pharmaceutically acceptable salt thereof;

- one or more proanthocyanidins; and

- Nw-methylserotonin;

in combination with

- ascorbic acid and/or a ginkgolide, preferably in the form of powdered Ginkgo biloba leaf;

b) the administration of a second composition, preferably in unit dosage form, comprising:

- hyaluronic acid or a pharmaceutically acceptable salt thereof;

- one or more proanthocyanidins; and

- Nw-methylserotonin;

in combination with

- one, two or three ingredients selected from valerenic acid, preferably in the form of Valeriana officinalis root extract; apigenin, preferably in the form of Matricaria recutita flower extract; and a magnesium source, preferably in the form of trimagnesium citrate;

wherein said first composition is administered in the morning, preferably within 5 hours after the female subject wakes up, and wherein said second composition is administered in the evening, preferably within 5 hours before the female subject goes to sleep.

11. The composition for use according to claim 10, wherein said first and said second composition are administered daily.

12. The composition for use according to claim 10 or 11 , wherein said first and said second composition are administered daily during a period of at least 1 month, preferably at least 6 months, more preferably at least 1 year.

13. A composition, preferably in unit dosage form, comprising

- hyaluronic acid or a pharmaceutically acceptable salt thereof;

- one or more proanthocyanidins; and

- Nw-methylserotonin; and

- ascorbic acid and/or a ginkgolide, preferably in the form of powdered Ginkgo biloba leaf;

14. A composition, preferably in unit dosage form, comprising

- hyaluronic acid or a pharmaceutically acceptable salt thereof;

- one or more proanthocyanidins; and

- Nw-methylserotonin; and

- one, two or three ingredients selected from valerenic acid, preferably in the form of Valeriana officinalis root extract; apigenin, preferably in the form of Matricaria recutita flower extract; and a magnesium source, preferably in the form of trimagnesium citrate.

15. Kit of parts comprising a plurality of first unit dosage forms having the composition as defined in claim 13, as well as a plurality of second unit dosage forms having the composition as defined in claim 14.

16. Kit of parts according to claim 15, further comprising printed instructions for using the product in the treatment a perimenopausal, menopausal or postmenopausal female subject in need thereof, by administering one of said first unit dosage forms in the morning, preferably within 5 hours after the female subject wakes up, and by administering one of said second unit dosage forms in the evening, preferably within 5 hours before the female subject goes to sleep.