Treatment of side effects of progestins and progesterone analogues used for birth control

• US 5,744,463 A
• Filed: 06/03/1996
• Issued: 04/28/1998
• Est. Priority Date: 06/03/1996
• Status: Expired due to Fees

• Current Assignee: Fem Diagnostics, LLC
• Original Assignee: Glenn O. Bair
• Inventors: Bair, Glenn O.
• Primary Examiner(s): JORDAN, KIMBERLY R
• Application Number:
  US08/656,737
• Time in Patent Office: 694 Days
• Field of Search: 514/170, 514/177, 514/922
• US Class Current: 514/177
• CPC Class Codes: A61K 31/569 substituted in position 17 alpha, e.g. ethisterone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol

Abstract

The present invention provides methods for treating the deleterious effects of progestins and progesterone analogues used for birth control. The invention also provides pharmaceutical compositions useful in those methods.

Claims

1. A method for treating the undesirable side effects of progestins or progesterone analogues administered for birth control in a human female, said method comprising the step of administering to said female a pharmaceutical composition comprising natural progesterone in an amount effective in alleviating said undesirable side effects and a pharmaceutically acceptable carrier.

2. The method according to claim 1, wherein said undesirable side effects are selected from headache, mood changes, nervousness, abdominal cramps, dizziness, weakness or fatigue, nausea, vaginal irritation, breast swelling and tenderness, bloating, swelling of the hands or feet, backache, depression, mastalgia, insomnia, acne rashes, hot flashes, angry outbursts, acute weight gain/loss, pain and swelling of the joints, hypertension, stroke, vomiting and combinations thereof.

3. The method according to claim 1, wherein the amount of natural progesterone administered to said female is between 200 mg/day to 20 gm/day.

4. The method according to claim 3, wherein the amount of natural progesterone administered to said female is between 2 gm/day to 10 gm/day.

5. The method according to claim 4, wherein the amount of natural progesterone administered to said female is between 6 gm/day to 9 gm/day.

6. The method according to any one of claims 1 to 5, wherein said progestin or progesterone analogue used for birth control is levonorgestrel.

7. The method according to any one of claims 1 to 5, wherein said progestin or progesterone analogue used for birth control is medroxyprogesterone acetate.

8. The method according to any one of claims 1 to 5, wherein said pharmaceutical composition is administered orally to the patient.

9. The method according to any one of claims 1 to 5, wherein said pharmaceutical composition is administered intravenously to the patient.

10. The method according to any one of claims 1 to 4, wherein said pharmaceutical composition is administered topically to the patient.