Study to Evaluate the Pharmacodynamics and Efficacy of Leuprolide Tablets (Ovarest®) in Women With Endometriosis

"If the subject during Treatment A meets the pharmacodynamic success criterion (estradiol level \<20 pg/mL on Treatment Day 29 of the First Treatment Cycle), in the Second Treatment Cycle, she will be assigned Treatment B - 80 mg (2 x 40 mg tablets) (QD), with food-intake restrictions.~If the subject during Treatment A fails to meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the First Treatment Cycle), then she will be switched to the Second Treatment Cycle with Treatment D - 60 mg (BID) with food intake restrictions."

"If the subject on Treatment B meets the pharmacodynamic success criterion (estradiol level \<20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment C - 60 mg (QD) with food-intake restrictions.~If the subject on Treatment B does not meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment E - 40 mg (BID) with food intake restrictions."

For up to 29 consecutive days with food-intake restrictions

"If the subject on Treatment D fails to meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), she will be discontinued from the study following completion of the Second Treatment Cycle.~If the subject during Treatment D meets the pharmacodynamic success criterion (estradiol level \<20 pg/mL on Treatment Day 29 of her Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment E - 40 mg (BID) with food intake restrictions."

For up to 29 consecutive days with food-intake restrictions