OBJECTIVE: To compare the contraceptive efficacy, bleeding pattern, acceptability and safety of desogestrel 75 micrograms/day (Cerazette) as a progestogen-only formulation to levonorgestrel 30 micrograms/day in healthy female subjects. METHODS: In a double-blind, randomized, group-comparative, multicenter trial, 989 subjects were randomized to desogestrel 75 micrograms/day and 331 to levonorgestrel 30 micrograms/day. The women were observed during 13 consecutive treatment periods of 28 days. RESULTS: The Pearl indices for in-treatment pregnancies, excluding gross non-compliance, were 0.14 (one pregnancy in 727 woman-years) in the desogestrel group and 1.17 (three pregnancies in 257 woman-years) in the levonorgestrel group. Using the 90-day reference period for assessing the bleeding pattern, desogestrel users had a higher incidence of amenorrhea and infrequent bleeding on the one hand, and of frequent bleeding and prolonged bleeding on the other hand, at the beginning of the study period. In contrast to the levonorgestrel group, a tendency towards less bleeding over time was observed in the desogestrel group. The frequency and pattern of adverse experiences were comparable for desogestrel 75 micrograms/day and levonorgestrel 30 micrograms/day. CONCLUSIONS:Desogestrel 75 micrograms/day is a reliable and safe progestogen-only pill with a contraceptive efficacy superior to levonorgestrel 30 micrograms/day. These was a similar overall acceptability of desogestrel 75 micrograms/day and levonorgestrel 30 micrograms/day.
RCT Entities:
OBJECTIVE: To compare the contraceptive efficacy, bleeding pattern, acceptability and safety of desogestrel 75 micrograms/day (Cerazette) as a progestogen-only formulation to levonorgestrel 30 micrograms/day in healthy female subjects. METHODS: In a double-blind, randomized, group-comparative, multicenter trial, 989 subjects were randomized to desogestrel 75 micrograms/day and 331 to levonorgestrel 30 micrograms/day. The women were observed during 13 consecutive treatment periods of 28 days. RESULTS: The Pearl indices for in-treatment pregnancies, excluding gross non-compliance, were 0.14 (one pregnancy in 727 woman-years) in the desogestrel group and 1.17 (three pregnancies in 257 woman-years) in the levonorgestrel group. Using the 90-day reference period for assessing the bleeding pattern, desogestrel users had a higher incidence of amenorrhea and infrequent bleeding on the one hand, and of frequent bleeding and prolonged bleeding on the other hand, at the beginning of the study period. In contrast to the levonorgestrel group, a tendency towards less bleeding over time was observed in the desogestrel group. The frequency and pattern of adverse experiences were comparable for desogestrel 75 micrograms/day and levonorgestrel 30 micrograms/day. CONCLUSIONS:Desogestrel 75 micrograms/day is a reliable and safe progestogen-only pill with a contraceptive efficacy superior to levonorgestrel 30 micrograms/day. These was a similar overall acceptability of desogestrel 75 micrograms/day and levonorgestrel 30 micrograms/day.
Authors: Kari White; Joseph E Potter; Kristine Hopkins; Leticia Fernández; Jon Amastae; Daniel Grossman Journal: Contraception Date: 2012-02-24 Impact factor: 3.375
Authors: Giovanni Grandi; Pierluigi Di Vinci; Alice Sgandurra; Lia Feliciello; Francesca Monari; Fabio Facchinetti Journal: Int J Womens Health Date: 2022-07-15