Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system: pooled analysis from Phase 3 trials
| Autor: | Jeffrey T. Jensen, Marlena Gehret Plagianos, Ruth Merkatz, Diana L. Blithe, Regine Sitruk-Ware, Carolina Sales Vieira, Vivian Brache, Carolyn Westhoff, Ian S. Fraser, Luis Bahamondes, Anne E. Burke |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
medicine.medical_specialty Adolescent Logistic regression Ethinyl Estradiol Article 03 medical and health sciences Young Adult 0302 clinical medicine Pregnenediones Medicine Humans Vaginal bleeding 030212 general & internal medicine 030219 obstetrics & reproductive medicine business.industry Obstetrics Obstetrics and Gynecology Odds ratio Confidence interval Discontinuation CONTROLE DE NATALIDADE Menstruation Clinical trial Drug Combinations Pooled analysis Reproductive Medicine Segesterone acetate Female medicine.symptom business |
| Zdroj: | Contraception Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual) Universidade de São Paulo (USP) instacron:USP |
| ISSN: | 1879-0518 |
| Popis: | 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 [ 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. |
| Databáze: | OpenAIRE |
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