Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation.

ABSTRACT:

Objectives

To evaluate safety outcomes from clinical studies of a 12-month contraceptive vaginal system (CVS) releasing an average of segesterone acetate (SA) 150 mcg and ethinyl estradiol (EE) 13 mcg daily.

Study design

We integrated clinical safety data from nine studies in which women used the CVS for 21 consecutive days and removed it for 7 days of each 28-day cycle. Four studies used the final manufactured CVS, including a 1-year pharmacokinetic study, two 1-year phase 3 trials and a second-year treatment extension study. We assessed safety by evaluating adverse events women reported in a daily diary. We also included data from focused safety studies evaluating endometrial biopsies, vaginal microbiology and liver proteins from one of the phase 3 studies.

Results

SUBMITTER: Gemzell-Danielsson K 

PROVIDER: S-EPMC7357828 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature