Multinational, multicentre, randomised, open-label study evaluating the impact of a 91-day extended regimen combined oral contraceptive, compared with two 28-day traditional combined oral contraceptives, on haemostatic parameters in healthy women

Rossella E. Nappi, Anna Maria Paoletti, Annibale Volpe, Luca Chiovato, Brandon Howard, Herman Weiss, Nancy Ricciotti

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives To evaluate the impact of a 91-day extended regimen combined oral contraceptive (150 μg levonorgestrel [LNG]/30 μg ethinylestradiol [EE] for 84 days, followed by 10 μg EE for seven days [Treatment 1]) compared with two traditional 21/7 regimens (21 days 150 μg LNG/30 μg EE [Treatment 2] or 150 μg desogestrel [DSG]/30 μg EE [Treatment 3], both with seven days' hormone free), on several coagulation factors and thrombin formation markers. Methods Randomised, open-label, parallel-group comparative study involving healthy women (18-40 years). The primary endpoint was change from baseline in prothrombin fragment 1 + 2 (F1 + 2) levels over six months. Results A total of 187 subjects were included in the primary analysis. In all groups, mean F1 + 2 values were elevated after six months of treatment. Changes were comparable between Treatments 1 and 2 (least squares mean change: 170 pmol/L and 158 pmol/L, respectively) but noticeably larger after Treatment 3 (least squares mean change: 592 pmol/L). The haemostatic effects of Treatment 1 were comparable to those of Treatment 2 and noninferior to those of Treatment 3 (lower limit of 95% confidence interval [- 18.3 pmol/L] > - 130 pmol/L). Conclusions The LNG/EE regimens had similar effects on F1 + 2. Noninferiority was demonstrated between extended regimen LNG/EE and DSG/EE.

Original languageEnglish
Pages (from-to)285-294
Number of pages10
JournalEuropean Journal of Contraception and Reproductive Health Care
Volume19
Issue number4
DOIs
Publication statusPublished - 2014

Keywords

  • Coagulation
  • Combined oral contraceptives
  • Desogestrel
  • Haemostatic
  • Levonorgestrel

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Pharmacology (medical)
  • Reproductive Medicine
  • Medicine(all)

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