Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system

pooled analysis from Phase 3 trials

Carolina Sales Vieira, Ian S. Fraser, Marlena G. Plagianos, Anne E. Burke, Carolyn L. Westhoff, Jeffrey Jensen, Vivian Brache, Luis Bahamondes, Ruth Merkatz, Regine Sitruk-Ware, Diana L. Blithe

Research output: Contribution to journalArticle

Abstract

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 [<high school (AOR=0.62, 95% CI=0.43–0.90); high school graduate (AOR: 0.76, 95% CI=0.60–0.97)] were less likely to report any episode of unscheduled B/S compared to college graduates. Conclusions: Participants using the SA/EE CVS up to 13 cycles reported good cycle control. Discontinuation due to unacceptable bleeding was very low. Further research into demographic/other differences with reported unscheduled bleeding is warranted. Implications: Since good cycle control is a key factor influencing contraceptive selection, adherence and continuation of combined hormonal contraceptives, the favorable bleeding profiles experienced by women during the SA/EE CVS clinical trials provide reassuring information for prospective users.

Original languageEnglish (US)
JournalContraception
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Ethinyl Estradiol
Contraceptive Agents
Acetates
Metrorrhagia
Hemorrhage
Odds Ratio
Confidence Intervals
Uterine Hemorrhage
Appointments and Schedules

Keywords

  • Bleeding patterns
  • Combined hormonal contraceptives
  • Contraceptive vaginal system
  • Nestorone
  • Segesterone acetate

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system : pooled analysis from Phase 3 trials. / Vieira, Carolina Sales; Fraser, Ian S.; Plagianos, Marlena G.; Burke, Anne E.; Westhoff, Carolyn L.; Jensen, Jeffrey; Brache, Vivian; Bahamondes, Luis; Merkatz, Ruth; Sitruk-Ware, Regine; Blithe, Diana L.

In: Contraception, 01.01.2019.

Research output: Contribution to journalArticle

Vieira, Carolina Sales ; Fraser, Ian S. ; Plagianos, Marlena G. ; Burke, Anne E. ; Westhoff, Carolyn L. ; Jensen, Jeffrey ; Brache, Vivian ; Bahamondes, Luis ; Merkatz, Ruth ; Sitruk-Ware, Regine ; Blithe, Diana L. / Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system : pooled analysis from Phase 3 trials. In: Contraception. 2019.
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abstract = "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 [",
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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.

PY - 2019/1/1

Y1 - 2019/1/1

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