Estrogen suppression of 8-week treatment with exemestane combined with triptorelin versus triptorelin alone in healthy premenopausal women

2041 Background: Gonadotrophin-releasing hormone agonists (Gn-RHa), such as triptorelin (T), reduce the ovarian estrogen production in premenopausal women, thus inducing a reversible postmenopausal status. Aromatase inhibitors, such as exemestane (EX), are effective in inhibiting the extraovarian estrogen production in postmenopausal women. Methods: We conducted a randomized, double-blind study evaluating the endocrinological effects of EX or placebo (P) given in combination with T in healthy premenopausal volunteers. EX (Aromasin 25 mg) or P were given orally, once daily, starting on Study Day 1, for 8 weeks in 14 subjects per arm. T pamoate (Trelstar Depot 3.75 mg) was given IM twice, 4 weeks apart, on Study Day 1 and 29. Blood was collected at several pre-planned intervals from Day 1 to 73. The primary objective was to demonstrate greater estradiol (E2) suppression in the T+EX group, determined from the E2 AUCday 36–57. Results: E2 levels below the “castration threshold” of 20 pg/mL, an index of the ov...