TY - JOUR
T1 - Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system
T2 - pooled analysis from Phase 3 trials
AU - Vieira, Carolina Sales
AU - Fraser, Ian S.
AU - Plagianos, Marlena G.
AU - Burke, Anne E.
AU - Westhoff, Carolyn L.
AU - Jensen, Jeffrey
AU - Brache, Vivian
AU - Bahamondes, Luis
AU - Merkatz, Ruth
AU - Sitruk-Ware, Regine
AU - Blithe, Diana L.
N1 - Funding Information:
The authors would like to thank the participating study investigators and coordinators at the 27 clinical sites for conduct of the two Phase 3 clinical trials and the 2200+ women participants from eight countries. These trials were supported by the National Institute of Child Health and Human Development of the National Institutes of Health (Contract Numbers HD43366003, HD43371003, HD43372003, HD43373003, HD43374003, HD43375003, HD43376003, HD43377003, HD43378003, HD43379003, HD43380003, HD43381003, HD43382003), and the United States Agency for International Development (Grant Number GPO-A-00-04-00019-00), as well as financial support from WHO's RHRP Division for two clinical sites in Europe, and the Population Council.
Funding Information:
These trials were supported by the National Institute of Child Health and Human Development of the National Institutes of Health (Contract Numbers HD43366003, HD43371003, HD43372003, HD43373003, HD43374003, HD43375003, HD43376003, HD43377003, HD43378003, HD43379003, HD43380003, HD43381003, HD43382003), and the United States Agency for International Development (Grant Number GPO-A-00-04-00019-00), as well as financial support from WHO's RHRP Division for two clinical sites in Europe, and the Population Council.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/12
Y1 - 2019/12
N2 - Objectives: To describe bleeding patterns among users of the segesterone acetate (SA) and ethinyl estradiol (EE) contraceptive vaginal system (CVS), and identify factors associated with unscheduled bleeding/spotting (B/S). Study design: We pooled results from two multicenter, single-arm, open-label, pivotal, phase 3 studies of the SA/EE CVS conducted in 17 US and 7 international sites. Participants (age 18–40 years; BMI ≤29 kg/m2) followed a 21/7-day in/out schedule of CVS use for up to 13 cycles and recorded vaginal bleeding daily in paper diaries. Scheduled and unscheduled B/S were summarized by cycle. We used multiple logistic regression to identify factors associated with unscheduled bleeding/spotting, based on the first 4 cycles only. Results: Analysis included data from 2070 participants (16,408 cycles). Ninety-eight percent documented scheduled B/S [mean (SD): 4.9 (1.1) days/cycle)]. Absence of scheduled B/S was 5–8% of women/cycle. Unscheduled B/S ranged from 13.2% to 21.7% of women per cycle. Few women (1.8%) discontinued prematurely due to unacceptable bleeding. Black women were more likely to report unscheduled B/S than White women [Adjusted odds ratio (AOR) = 1.49, 95% confidence interval (CI) = 1.14–1.94]. Women with fewer years of schooling [
AB - Objectives: To describe bleeding patterns among users of the segesterone acetate (SA) and ethinyl estradiol (EE) contraceptive vaginal system (CVS), and identify factors associated with unscheduled bleeding/spotting (B/S). Study design: We pooled results from two multicenter, single-arm, open-label, pivotal, phase 3 studies of the SA/EE CVS conducted in 17 US and 7 international sites. Participants (age 18–40 years; BMI ≤29 kg/m2) followed a 21/7-day in/out schedule of CVS use for up to 13 cycles and recorded vaginal bleeding daily in paper diaries. Scheduled and unscheduled B/S were summarized by cycle. We used multiple logistic regression to identify factors associated with unscheduled bleeding/spotting, based on the first 4 cycles only. Results: Analysis included data from 2070 participants (16,408 cycles). Ninety-eight percent documented scheduled B/S [mean (SD): 4.9 (1.1) days/cycle)]. Absence of scheduled B/S was 5–8% of women/cycle. Unscheduled B/S ranged from 13.2% to 21.7% of women per cycle. Few women (1.8%) discontinued prematurely due to unacceptable bleeding. Black women were more likely to report unscheduled B/S than White women [Adjusted odds ratio (AOR) = 1.49, 95% confidence interval (CI) = 1.14–1.94]. Women with fewer years of schooling [
KW - Bleeding patterns
KW - Combined hormonal contraceptives
KW - Contraceptive vaginal system
KW - Nestorone
KW - Segesterone acetate
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U2 - 10.1016/j.contraception.2019.07.145
DO - 10.1016/j.contraception.2019.07.145
M3 - Article
C2 - 31398307
AN - SCOPUS:85071482842
SN - 0010-7824
VL - 100
SP - 438
EP - 444
JO - Contraception
JF - Contraception
IS - 6
ER -