Synthetic progestogens and pharmaceutical compositions comprising the same

A pharmaceutical composition comprising:

• micronized 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone, wherein the 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone is present in an amount ranging from 3 milligrams (mg) to 4.5 mg;
• and
• one or more pharmaceutically acceptable excipients,
• wherein the pharmaceutical composition does not comprise estrogen;
• and
• wherein the pharmaceutical composition is formulated such that:
• (1) when orally administered to a patient under fasting conditions, the pharmaceutical composition provides a pharmacokinetic profile for the 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone comprising:
• (i) a mean Tmax ranging from 2.2 hours to 6 hours;
• and
• (ii) a mean Cmax of less than 30 ng/ml;
• and
• (2) no more than 50% of the 6β,7β:15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone initially present in the pharmaceutical composition is dissolved within 30 minutes if subjected to an in vitro dissolution test according to the USP XXIII Paddle Method.