OBJECTIVES: This multicenter, randomized, parallel-group, open-label study was conducted to compare the effects of gestodene (GTD) 60 microg/ethinylestradiol (EE) 15 microg and desogestrel (DSG) 150 microg/EE 20 microg (Mercilon) on selected metabolic measurements during six cycles in 124 healthy women. METHODS: GTD/EE subjects received a single pill once daily from days 1 to 24 of a 28-day cycle, followed by placebo pills daily for the last 4 days of the cycle. DSG/EE subjects received a single pill daily from days 1 to 21 of a 28-day cycle, followed by a 7-day pill-free interval. Safety was assessed from changes in hemostatic measurements, lipid profile, glucose tolerance and adverse events. RESULTS: Both GTD/EE and DSG/EE groups exhibited minimal effects on the lipid profile. An increased glucose response was noted with both treatments and an increased insulin response was noted with GTD/EE. Hemostatic activity was increased in both groups but a counteracting increase in fibrinolytic activity occurred together with an increase in coagulatory activity. The incidence of adverse events was comparable between groups, and no significant differences in cycle control were observed between groups. No pregnancies occurred in either group. CONCLUSIONS: The 24-day GTD 60 microg/EE 15 microg formulation and DSG/EE produced similar effects on hemostatic balance, lipid metabolism and glucose tolerance, and exhibited comparable efficacy and tolerability.
RCT Entities:
OBJECTIVES: This multicenter, randomized, parallel-group, open-label study was conducted to compare the effects of gestodene (GTD) 60 microg/ethinylestradiol (EE) 15 microg and desogestrel (DSG) 150 microg/EE 20 microg (Mercilon) on selected metabolic measurements during six cycles in 124 healthy women. METHODS: GTD/EE subjects received a single pill once daily from days 1 to 24 of a 28-day cycle, followed by placebo pills daily for the last 4 days of the cycle. DSG/EE subjects received a single pill daily from days 1 to 21 of a 28-day cycle, followed by a 7-day pill-free interval. Safety was assessed from changes in hemostatic measurements, lipid profile, glucose tolerance and adverse events. RESULTS: Both GTD/EE and DSG/EE groups exhibited minimal effects on the lipid profile. An increased glucose response was noted with both treatments and an increased insulin response was noted with GTD/EE. Hemostatic activity was increased in both groups but a counteracting increase in fibrinolytic activity occurred together with an increase in coagulatory activity. The incidence of adverse events was comparable between groups, and no significant differences in cycle control were observed between groups. No pregnancies occurred in either group. CONCLUSIONS: The 24-day GTD 60 microg/EE 15 microg formulation and DSG/EE produced similar effects on hemostatic balance, lipid metabolism and glucose tolerance, and exhibited comparable efficacy and tolerability.
Authors: Richard S Legro; Silva A Arslanian; David A Ehrmann; Kathleen M Hoeger; M Hassan Murad; Renato Pasquali; Corrine K Welt Journal: J Clin Endocrinol Metab Date: 2013-10-22 Impact factor: 5.958
Authors: Lina S Silva-Bermudez; Freddy J K Toloza; Maria C Perez-Matos; Russell J de Souza; Laura Banfield; Andrea Vargas-Villanueva; Carlos O Mendivil Journal: Endocr Connect Date: 2020-10 Impact factor: 3.335