Dose-finding study of a 90-day contraceptive vaginal ring releasing estradiol and segesterone acetate.

ABSTRACT:

Objective

To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism.

Study design

We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information.

Results

Sixty-five participants

SUBMITTER: Chen MJ 

PROVIDER: S-EPMC7483386 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature