Pooled analysis of bleeding profile, efficacy and safety of oral oestradiol valerate/dienogest in women aged 25 and under

Jeffrey T. Jensen, Johannes Bitzer, Rossella E. Nappi, Christiane Ahlers, Ralf Bannemerschult, Susanne Parke

Research output: Contribution to journalArticle

Abstract

Purpose: To evaluate differences in key outcomes between younger and older women receiving the oral contraceptive oestradiol valerate/dienogest (E2V/DNG). Methods: We conducted a pooled post hoc analysis of primary data from 12 studies of E2V/DNG, stratified by age (≤25 [n = 1309] and >25 [n = 2132] years). Outcomes included safety, efficacy, bleeding profile and hormone-withdrawal-associated symptoms (HWAS). Bleeding and HWAS analyses are also presented for women aged ≤20 years (n = 362). Discontinuations were considered a proxy for patient satisfaction. Results: Results were generally similar for younger and older women. The percentage of women aged ≤25 and >25 years experiencing intracyclic bleeding did not differ between groups (13.4% and 12.8% at cycle 12, respectively), with similar results in women aged ≤20 years (12.7%, cycle 12). Rates of withdrawal bleeding were very similar in women aged ≤25 and >25 years (78.5% and 78.9%, respectively, cycle 12). We also found a similar adjusted Pearl index in the two age groups (0.45 vs 0.57, respectively), similar rates of AEs and HWAS and no difference in discontinuations. Conclusions: Women aged ≤25 and >25 years have a similar experience with an E2V/DNV oral contraceptive, supporting this as an appropriate contraceptive option in younger and older women.

Original languageEnglish (US)
Pages (from-to)98-105
Number of pages8
JournalEuropean Journal of Contraception and Reproductive Health Care
Volume25
Issue number2
DOIs
StatePublished - Mar 3 2020

Keywords

  • bleeding
  • dienogest
  • hormone-withdrawal-associated symptoms
  • oestradiol valerate
  • Oral contraceptive
  • safety
  • young women

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Pharmacology (medical)

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