CYPROTERONE ACETATE COMPOSITIONS AND USES THEREOF
Provided herein are oral drug preparations including cyproterone acetate and ethinylestradiol, dosing regimen for the drug preparations, and methods of treating diseases. The methods provided include the administration of the oral drug preparation to treat one or more symptoms of hyperandrogenic conditions or hyperandrogenic activities, to provide contraception, and to reduce a risk of vascular thromboembolism (VTE) in a subject.
1 . An oral drug preparation comprising:
(a) a first composition comprising about 5 to 50 μg ethinylestradiol (EE) and about 1 to 10 mg cyproterone acetate (CPA); and
(b) a second composition consisting essentially of about 1 to 10 mg CPA.
2 . The preparation of claim 1 , wherein the first composition is administered to the subject: daily beginning on day 1 of a 14 day dosing schedule and for 14 consecutive days, inclusive, and every other day beginning on day 16 of the dosing schedule and wherein the second composition is administered beginning on day 15 of the dosing schedule and then every other day.
3 . The preparation of claim 1 , wherein the first composition comprises about 35 μg EE and about 2 mg CPA.
4 . The preparation of claim 1 , wherein the CPA in the second composition is about 2 mg CPA.
5 . The preparation of claim 1 , wherein the dosing schedule is about 84 days.
6 . The preparation of claim 1 , further comprising a third composition comprising no active ingredient.
7 . The preparation of claim 6 , wherein beginning the day following the last day of the dosing schedule, the third composition with no active ingredient is administered daily for 4 to 7 consecutive days, inclusive.
8 . An oral drug preparation comprising:
(a) a first composition comprising about 5 to 50 μg ethinylestradiol (EE) and about 1 to 10 mg cyproterone acetate (CPA); and
(b) a second composition consisting essentially of about 1 to 10 mg CPA.
9 . The preparation of claim 8 , wherein the first composition comprises about 35 μg EE and about 2 mg CPA.
10 . The preparation of claim 8 , wherein the CPA in the second composition is about 2 mg CPA.
11 . The preparation of claim 8 , wherein beginning on day 1 of a dosing schedule, the first composition is administered on day 1 and then every other day; and on day 8 of a dosing schedule, the second composition is administered on day 8 and then every other day.
12 . The preparation of claim 11 , wherein beginning on day 2 of the dosing schedule, the second composition is further administered on day 2 and then every other day.
13 . The preparation of claim 11 , wherein the first composition is administered to the subject: daily beginning on day 1 of the dosing schedule and for 7 consecutive days, inclusive, and every other day beginning on day 9 of the dosing schedule.
14 . The preparation of claim 11 , wherein the dosing schedule comprises 21, 28, 49 or 84 days.
15 . The preparation of claim 8 , further comprising a third composition comprising no active ingredient.
16 . The preparation of claim 15 , wherein beginning the day following the last day of the dosing schedule, the third composition with no active ingredient is administered daily for 4 to 7 consecutive days, inclusive.
17 . An oral drug preparation comprising:
a) a first composition comprising about 5 to 50 μg ethinylestradiol (EE) and about 1 to 10 mg cyproterone acetate (CPA); and
b) a second composition comprising about 5 to 50 μg ethinylestradiol (EE) and about 1 to 10 mg cyproterone acetate (CPA);
wherein the second composition comprises a lower amount of EE as compared to the first composition.
18 . The preparation of claim 17 , wherein the first composition is administered on day 1 of a 30-day dosing schedule and then on alternating days.
19 . The preparation of claim 17 , wherein the first composition comprises about 35 μg EE and about 2 mg CPA and the second composition comprises about 15 μg EE and about 2 mg CPA.
20 . A method of treating one or more symptoms of hyperandrogenic conditions or hyperandrogenic activities in a subject comprising administering to the subject the preparation of claim 1 , thereby treating one or more symptoms of hyperandrogenic conditions or hyperandrogenic activities in the subject.