Steroidal Compositions

An oral unit dosage form that provides a therapeutically effective amount of testosterone to a hypogonadal male comprising from about 70 to 150 mg of testosterone undecanoate and a pharmaceutically acceptable carrier in an amount sufficient to provide a therapeutically effective amount of testosterone undecanoate to a hypogonadal male, wherein said oral unit dosage form provides a testosterone equivalent dose to mean testosterone AUC0-∞ ratio of about 600×10−3 mL/h or less, prepared by the process of:

• (a) providing testosterone undecanoate in an amount sufficient to give from 70 mg to about 150 mg, about 80 mg to about 140 mg, about 90 mg to about 140 mg, about 100 mg to about 130 mg, about 110 mg to about 130 mg, or about 120 mg per oral unit dosage form;
• (b) providing a pharmaceutically acceptable carrier in an amount sufficient to provide a therapeutically effective amount of testosterone undecanoate to a hypogonadal male;
• (c) combining the testosterone undecanoate and pharmaceutically acceptable carrier;
• and
• (d) forming the oral unit dosage form having from about 70 mg to about 150 mg, about 80 mg to about 140 mg, about 90 mg to about 140 mg, about 100 mg to about 130 mg, about 110 mg to about 130 mg, or about 120 mg testosterone undecanoate per oral unit dosage form that provides a therapeutically effective amount of testosterone to a hypogonadal male upon administration of one or multiple unit dosage forms with a meal twice a day.

An oral unit dosage form having from about 70 mg to about 150 mg testosterone undecanoate, 10-30% w/w of a hydrophilic carrier, 40-70% w/w of a lipophilic carrier and 5 to 10% w/w of a solidifying agent prepared by the process of:

• (a) combining an amount of testosterone undecanoate to give from about 70 mg to 150 mg testosterone undecanoate per unit dosage form and a carrier mixture of 10-30% w/w of a hydrophilic carrier, 40-70% w/w of a lipophilic carrier, and 5 to 10% w/w of a solidifying agent per unit dosage form to give a molten solution, wherein the carrier mixture is heated to a temperature elevated above ambient room temperature to give a molten carrier solution and the testosterone undecanoate is added thereto;
• (b) depositing an amount of the molten carrier solution having testosterone undecanoate on a substrate to give a unit dosage form;
• and
• (c) allowing the unit dosage form to cool to produce a solid, semi-solid, paste, gel or jelly thereby providing an oral unit dosage form.